Domusindo Perdana drop-side crib Recall
March 28, 2013 - The Consumer Product Safety Commission has issued a recall for about 73,000 PT Domusindo Perdana drop-side cribs because they pose an entrapment and suffocation hazard.
The cribs were sold exclusively at JC Penney through their website and catalog from January 1998 through December 2008 for between $200 and $400.
The CPSC says the the drop sides can "malfunction, detach or otherwise fail" causing them to create a space in which an infant or toddler can become trapped.
The recall applies to the following 14 models of PT Domusindo Perdana wooden drop-side cribs:
Model # 343-1509 Jenny Lind Crib with date code 01/1991-12/1997151
Model # 343-3810 Christopher Crib with date code 2001151
Model # 343-5500 Early American Crib with date code 01/1998-12/1999151
Model # 343-6771 Scottsdale Crib with date code 01/1998/12/1999151
Model # 343-7100 Sleigh Crib without Rosette with date code 01/2004-12/2006
Model # 343-7134 Sleigh Crib with date code 01/2001-2/2004
Model # 343-7144 Anniversary Sleigh Crib with date code 01/2002-12/2004
Model # 343-7753 Kristin Crib with date code 01/1998-12/1999
Model # 343-8249 Cameron Crib with date code 01/1998/12/1999
Model # 343-8020 Solid Panel Sleigh Crib with date code 01/2001-12/2002
Model # 343-8070 Roll Bar Convertible Crib with date code 01/2004-12/2005
Model # 343-8155 Anniversary Convertible Sleigh Crib with date code 01/2002-12/2006
Model # 343-8200 Spindle Convertible Crib with date code 01/2001-12/2005
Mode # 343-8913 Bella 3-in-1 Crib with date code 01/2005-12/2008
The codes are printed on the plywood mattress board.
Consumers should immediately stop using the crib and contact customer service at Modus Furniture at 800-827-2129. The phone line is open Monday through from 8 a.m. to 5 p.m. More on the Crib Recall here
FDA warns on antibiotic drug Zithromax
March 19, 2013 Disturbing news has been announced about serious heart problems, some of which could become fatal, linked to the popular antibiotic azithromycin, which is frequently sold as Zithromax, Zmax or in a Z-Pak.
In its warning, the FDA alerted the public and health care professionals that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm.
"Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias.
First award issued in a defective DePuy Hip Implant Lawsuit
March 8, 2013 Jurors in the first ever DePuy ASR hip implant trail held in Los Angeles California has awarded Loran Kransky $338,236.12 in economic and $8 million in non-economic damages. Back in 2007 Loran had a DePuy (Johnson & Johnson subsidiary) ASR hip implant installed. These metal on metal hip implants have a number of problems associated with them. Read more below about the problems and adverse side effects of these hip implants
SimplyThick Formula Thickener Lawsuits Now Being Accepted: FDA Cites Deaths, Life-Threatening Illnesses from Product
March 5, 2013 - If you or a loved one has an infant who suffered serious health problems or died as a result of the use of SimplyThick formula thickener you may be eligible to file a SimplyThick lawsuit and seek compensation.
Our experienced, aggressive lawyers are now investigating claims from families who have children who have been affected by this product. Please contact us as soon as possible to ensure that all of your legal rights are protected.
There may be time limits involved in certain cases and the earlier you contact us the more effectively we can begin pursuing compensation in cases in which eligibility is determined.
Free consultations are being offered to advise families about the legal options that may be available to them in seeking compensation for the loss of a child, medical costs, pain and suffering or other expenses that may have been incurred as a result of this product.
Johnson & Johnson MUST PAY $7.76 Million in Vaginal Mesh Case.
February 28, 2013 - A major punitive damages award for Linda Gross from South Carolina, to the tune of $7.76 MILLION DOLLARS in a New Jersey court from over Johnson & Johnson case involving their vaginal-mesh device. This is on top of the $3.35 million compensatory award for injuries she incurred from the use of the company's vaginal-mesh device, a New Jersey jury ruled.
MIRENA IUD MIGRATION PROBLEMS GENERATE LAWSUITS;
FDA WAS NOT HAPPY WITH ADS PROMOTING THE DEVICE
January 29, 2013 - With the much-publicized problem of birth control devices causing serious health problems for women and the infants they may bear many of them are wondering where to turn in order to preserve their health and any future offspring.
In the case of the Mirena intrauterine device a large number of women are turning to Mirena IUD migration lawyers who are aggressively seeking compensation for the health problems caused by these widely used contraceptives.
Free consultations are being offered to Mirena IUD victims who wish to join in litigation that has grown in such numbers that federal court officials are now considering consolidating the lawsuits into what could become a massive class-action case.
Pharmaceutical giant Bayer is now defending itself against claims filed by a growing number of women who allege the devices are faulty and have caused such devastating health problems as organ damage, ectopic pregnancies and infertility.
First approved by the U.S. Food and Drug Administration in 2000, the Mirena IUD is a t-shaped device that physicians implant into the uterus and is supposed to stay in place for up to five years and prevent conception.
The Mirena IUD also was the first such device approved by the FDA to treat women suffering from heavy menstrual bleeding. The device has been a huge commercial success for Bayer because millions of women have chosen it as their form of birth control.
However, warning signs about problems with the product soon began surfacing and thousands of women filed adverse event reports with the FDA complaining about serious complications as a result of their use of the Mirena IUD.
FDA internal statistics show that more than 45,000 such reports have been filed with the agency, and that about 6 percent have forced women to undergo surgery or hospitalization to treat their problems.
The numerous complaints caused the FDA in 2008 to announce labeling changes ordered to provide women increased information about these problems. Here are some of them:
- Ectopic Pregnancy
- Ovarian Cysts
Federal regulations also recommended precautions in which Mirena IUDs should be removed for:
- Pelvic Infection
- Drug Interactions
- Nursing Mothers
The FDA also provided this information to health care professionals:
Ectopic Pregnancy: Up to half of pregnancies that occur with Mirena in place are ectopic. The incidence of ectopic pregnancy in clinical trials that excluded women with risk factors for ectopic pregnancy was about 1 ectopic pregnancy per 1000 users per year.
Tell women who choose Mirena about the risks of ectopic pregnancy, including the loss of fertility. Teach them to recognize and report to their physician promptly any symptoms of ectopic pregnancy.
Sepsis: In some cases, severe pain occurred within hours of insertion followed by sepsis within days.
Perforation: Perforation or penetration of the uterine wall or cervix may occur during insertion although the perforation may not be detected until sometime later.
Ovarian Cysts: Surgical intervention is not usually required.
Then, in 2009, the FDA sent a warning letter to Bayer in which government officials said they had found that the Bayer’s advertising overstated the efficacy of Mirena while minimizing the health risks that women might suffer.
In the letter, the FDA warned Bayer:
"The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena. Thus, the program misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(n), and FDA’s implementing regulations. See 21 CFR 202.1(e)(3)(i), (e)(5) & (e)(6)(i)."
FIRST OF HUNDREDS OF JOHNSON & JOHNSON’S ETHICON
TRANSVAGINAL MESH TRIALS BEGINS IN NEW JERSEY COURT
January 25, 2013
Women who have suffered serious health complications from transvaginal mesh implants are closely watching a key trial that began this month in a New Jersey courtroom.
Pharmaceutical giant Johnson & Johnson, described as the world’s largest producer of medical products, is defending itself in the first of nearly 1,800 transvaginal mesh lawsuits filed by women who claim the products are defective and caused painful health problems.
The first case involves a South Dakota woman who had mesh implanted to treat a condition called pelvic organ prolapse in which weakening abdominal muscles cause organs to droop.
The woman claims that Johnson & Johnson’s subsidiary Ethicon’s Gynecare Prolift that was implanted in her in 2006 was defective and failed, leaving her in almost constant pain.
The 47-year-old woman, who is a former nurse, has had 18 other operations since in futile attempts to regain her health. Her attorneys claim that Johnson & Johnson is liable because it failed to warn her and other victims of the risks of transvaginal mesh and because the product was defectively designed.
“She can no longer sit comfortably for more than a few minutes without having to either stand up or lay down to try to reduce the level of pain,” the woman’s attorneys said in court papers filed in the case. “She requires various daily medications to treat her severe chronic pain.”
Tens of thousands of women have undergone operations in the United States in which transvaginal mesh was implanted to treat pelvic organ prolapse and another ailment common to women as they age, urinary incontinence.
However, products manufactured by companies including C.R.Bard , Gynecare, Johnson & Johnson, Mentor, Tyco
Covidien, American Medical Systems and Boston Scientific have been named in transvaginal mesh lawsuits by women who have made similar claims.
The 1,800 transvaginal mesh state court cases consolidated in New Jersey are among several sets of cases expected to begin going to trial this year in state and federal courts.
The safety of transvaginal mesh has long been controversial and many of the mesh products that are now the subject of lawsuits have either been recalled or are no longer being put on the market by their manufacturers.
The Food and Drug Administration has confirmed receiving a large number of “adverse event reports” from women who have suffered serious health side effects as a result of transvaginal mesh implants.
The FDA did issue a safety alert in 2008 concerning serious complications associated with transvaginal devices and later issued an “updated” warning with stronger language.
The most recent warning confirmed that serious complications associated with transvaginal surgical mesh were “not rare” and that pelvic organ prolapse can be treated just as effectively by other methods without mesh.
The FDA also has come under fire in the transvaginal mesh controversy over criticism from consumer advocates and transvaginal mesh victims that the agency’s review process for medical devices is flawed.
TRAGIC DETAILS SURFACE IN GRANUFLO,
NATURALYTE KIDNEY DIALYSIS LAWSUITS
Jan 18, 2013
In reviewing some of the many GranuFlo and NaturaLyte lawsuits that have been filed across the country it’s impossible not to be emotionally affected by the tragic stories told by people who have lost loved ones to deaths they are blaming on kidney dialysis concentrates.
GranuFlo and NaturaLyte are defending themselves against allegations that their products put patients at six times the risk of heart attacks, strokes or cardiac problems than patients who did not use the products.
The allegations include charges that the company was aware of these dangerous side effects, failed to adequately inform patients and health care professionals and attempted to cover up the reports it was receiving about these life-threatening issues.
In a recent suit that was filed against the manufacturer, Fresenius Medical Care, the world’s largest producer of dialysis products and services, a woman claims that the company is responsible for the death of her husband, who died soon after his last dialysis treatment in 2010
"After receiving defendants' defective product, he became ill during and after treatment, and went home,” the woman said her lawsuit. “He suffered at home in pain and tremendous weakness until he died later that same day."
In her complaint, the woman said her 50-year-old spouse’s death and those of others like him “were avoidable tragedies” caused by Fresenius.
“This preventable loss of life resulted directly from defendants' refusal to conduct proper safety studies; defective product design; suppression of information revealing life-threatening risks; wanton failure to provide adequate instructions; willful misrepresentation concerning the nature and safety of their product; and defendants' flagrant disregard for safety by failing to disclose the risks to health care providers.
"Despite being aware of research and clinical reports that foretold of these risks and evidenced that defendants' product formulation was flawed and that their warning instructions were inadequate, defendants disregarded, and even suppressed, the risks to the detriment of thousands of dialysis patients, including the decedent."
There have been so many lawsuits filed against the company by victims of these side effects and people who lost loved ones that the federal court system is in the process of creating a multi-district litigation in the matter.
Fresenius Medical Care has agreed to this process, in which a single judge oversees numerous lawsuits with common claims against a common defendant.
The action is the first step toward what can become a massive class-action case. NaturaLyte and GranuFlo kidney dialysis lawyers are currently offering free consultations to victims who have suffered such heart problems and wish to join in the litigation.
FDA ISSUES NEW SAFETY WARNING ABOUT RISKS OF METAL-ON-METAL HIP IMPLANT SYSTEMS
Jan 17, 2013 The Food and Drug Administration has issued a new safety warning informing health care professionals about the "unique risks" of metal-on-metal hip implant systems and the dangers they pose to patients.
Metal-on-metal systems have long been controversial over high failure rates and have been the subject of massive recalls and thousands of metal-on-metal hip implant lawsuits now pending in state and federal courts.
FDA officials said they are providing updated safety information and recommendations to patients and health care providers, based on the FDA's current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting.
As is the case in allegations filed in metal hip implant lawsuits against such manufacturers as DePuy, Stryker, Wright and Biomet the FDA warns that the metal ball and the metal cup slide against each other during walking or running.
These problems have caused patients such serious side effects that thousands of them have been recalled and manufacturers have admitted that some systems fail at rates of up to 13 percent.
FDA officials said metal can be released from other parts of the implant where two implant components connect and that metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint.
The FDA warns that soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery. Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body.
The FDA said that agency officials do not currently have enough scientific data to specify the concentration of metal ions in a patient's body or blood necessary to produce adverse systemic effects.
Officials also said that the reaction seems to be specific to individual patients, with different patients having different reactions to the metal wear particles.
The FDA said it has issued detailed recommendations for surgeons before the surgery and during patient follow-up, for imaging the implant, monitoring and assessing metal ion levels and considerations for device revision. Recommendations are also provided for patients considering hip implants and those with metal-on-metal hip implants.
The FDA said that prompt reporting of adverse events can help the agency identify and better understand the risks associated with medical devices such as the metal-on-metal hip implant systems.
Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Reports about adverse events related to metal-on-metal hip systems include, but are not limited to: pain, malposition, adverse local tissue reaction, metallosis, hypersensitivity (allergy), loosening, and dislocation.
The FDA said that in order to learn as much as possible about the adverse events associated with metal-on-metal hip implants, patients or health care professionals should include the following information in their reports:
- Date of implantation
- Date of implant removal (if applicable)
- Clinical cause for revision (if available)
- System components affected by the adverse event.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
In February 2011, the FDA launched a metal-on-metal hip implant webpage. Agency officials said they are providing updated safety information and recommendations to patients and health care providers.
This new information is based on the FDA's current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting.
The FDA recommended that follow-ups of asymptomatic patients with metal-on-metal hip implants, including physical examinations and routine radiographs, should occur periodically (typically every 1 to 2 years).
If the hip is functioning properly, the FDA does not believe there is a clear need to routinely perform additional soft tissue imaging or assess metal ion levels in the blood.
The FDA also alerted physicians to be aware that there are certain patients who are at risk for increased device wear and/or adverse local tissue reactions (ALTR) and should be followed more closely. They may include:
- Patients with bilateral implants
- Patients with resurfacing systems with small femoral heads (44mm or smaller)
- Female patients
- Patients receiving high doses of corticosteroids
- Patients with evidence of renal insufficiency
- Patients with suppressed immune systems
- Patients with suboptimal alignment of device components
- Patients with suspected metal sensitivity (e.g. cobalt, chromium, nickel)
- Patients who are severely overweight
- Patients with high levels of physical activity.
Physicians also were instructed to pay close attention to signs and symptoms that may be associated with metal-on-metal hip implants.
FDA ISSUES CLASS 1 RECALL OF FISHER&PAYKEL REUSABLE BREATHING CIRCUITS BECAUSE OF DANGEROUS PIN HOLES
Jan 15, 2013 FDA The Food and Drug Administration has issued a Class 1 Recall of the Fisher & Paykel Healthcare Reusable Breathing Circuit, Model 900MR068 because of pin holes that have been found in the tubes used in the reusable breathing circuit.
Agency officials have notified health care professionals that if these pinholes are not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy. Usage of the defective device may result in patient death.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The Fisher & Paykel Healthcare Reusable Breathing Circuit is a non-heated breathing circuit intended for oxygen therapy delivery for adult patients.
The FDA said that on Nov. 19, 2012, Fisher & Paykel issued an Urgent Medical Device Recall letter to inform customers of the problem and to provide them with a Product Recall Response form. Customers should examine their inventory and destroy and discard any affected circuits in their possession.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
STRYKER METAL HIP IMPLANT RECALL COSTS COULD REACH NEARLY $400 MILLION
Jan 10, 2013 Manufacturers of controversial metal-on-metal hip implant systems that have failed at rates of up to 13 percent have made a lot of money on these devices. Now, in the wake of medical research, government reports and thousands of metal hip implant lawsuits documenting serious side effects these companies may be facing massive payouts to victims.
In the most recent example, Stryker Corp. is reporting that a hip implant recall that the company initiated last year could cost investors up to $390 million in costs for patient testing and treatment, new surgeries, lawsuits and insurance payments.
There are currently tens of thousands of lawsuits over health problems caused by these medical devices and metal-on-metal hip implant lawyers are continuing to offer free consultations in such cases. Victims who have not filed such lawsuits are still eligible to do so, these lawyers say, but there may be legal time limits involved.
Reuters News Service reported that Stryker said it increased the low end of its expectations for these costs and as a result also raised its related financial reserves. It will result in a fourth-quarter charge of 35 cents per share, or $174 million before taxes, Stryker said.
The recall involves the company's Rejuvenate and ABG II modular-neck hip devices, which like similar systems manufactured by competitors such as DePuy, Biomet, Wright and others, have been identified as putting patients at risk of serious health problems because the systems are susceptible to corrosion.
When that occurs, a patient's body can be poisoned by metal particles that flake off, causing tissue damage, inflammation, severe pain and swelling. Those and other life-threatening side effects have been alleged in tens of thousands of metal hip implant lawsuits now pending in state and federal courts.
Reuters reported that the eventual total cost of the recall will depend on several variables, including the number of patients who require testing, follow-up procedures and the cost of lawsuits.
Typically, mass litigation involving class-action lawsuits over defective drugs or medical devices can result in settlement reaching into the hundreds of millions of dollars. Such payments are made to patients for medical costs, pain and suffering, loss of wages and other, related expenses.
On its web site Stryker advised all patients who have the Rejuvenate Modular or ABG II modular-neck hip implants to consult a doctor:
"It is important that you follow-up with your surgeon, even if you are not experiencing symptoms such as pain and/or swelling at or around your hip."
According to Reuters:
"Stryker's recall last summer followed similar action from other orthopedic device manufacturers, including Johnson & Johnson, which initiated the biggest hip recall and also subsequently hired Broadspire to help manage patient care and limit its financial exposure.
Hip implants made of all metal, known in the industry as metal-on-metal, have been especially problematic. In addition to high failure rates and other pitfalls, they may release metals into the bloodstream over time. It is unclear what the long-term consequences of high levels of metal in the blood may be.
'The issue of greatest concern is the potential for elevated metal ions in the bloodstream and the damage that can be caused to the muscles, tendons, soft tissue and bone,' said Dr. Mary O'Connor, an orthopedic surgeon at the Mayo Clinic in Jacksonville, Florida.
'Soft tissue damage is more critical than bone damage. If the bone is damaged, we can do something. But if the muscle is dead because it has been poisoned by metal ions, we can't recreate it,' she said."
MEDTRONIC WARNS OF DEADLY PROBLEMS INVOLVING UNAPPROVED DRUGS AND RECALLED INFUSION PUMPS
Jan 8, 2013 The U.S. Food and Drug Administration and medical device manufacturer Medtronic have issued a medical alert raising fears of possible life-threatening problems involving the use of unapproved drugs with the company's recalled infusion pumps.
In a joint announcement the FDA and Medtronic notified health care professionals that using unapproved drugs with the SynchroMed Infusion Pump may negatively impact the pump's performance.
They said the use of unapproved drugs can lead to intermittent or permanent pump motor stall and cessation of drug infusion, which may cause serious adverse health consequences, including death.
The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps were the subject of a Class 1 recall last November. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Medtronic, one of the nation's largest producers of medical devices, has been defending itself against numerous Infuse Bone Graft lawsuits filed by victims of serious side effects.
The company was recently rejected in its efforts to convince a judge to dismiss a lawsuit filed by a woman who suffered serious health problems after having a Medtronic Infuse Bone Graft in her neck.
The Los Angeles Superior Court judge denied Medtronic's request that they be granted summary judgment, or a judge's ruling that would have found that the facts in the case did not merit a trial.
Instead, the woman will be allowed to continue her efforts to prove that Medtronic should be found to have committed fraud and negligence that caused her to suffer her injuries.
Other victims who have been injured because of a malfunctioning Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump may also be eligible to join a class action lawsuit. Those who used these infusion pumps and believe they may have been hurt because of it can seek free consultations from a personal injury or medical malpractice lawyer.
In the FDA's announcement of the Class 1 Recall of the Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits the agency said the pump and infusion system are used in patients undergoing therapy that requires the constant delivery of drugs or fluids into a patient's body. The refill kit is used in refilling most Medtronic implantable infusion pumps.
The federal agency warned that pocket fills, or the unintended injection of drugs or fluids into the patient's subcutaneous tissue at the pump pocket site instead of the pump, may result in patient harm, serious injury and/or death due to drug overdose or underdose.
The affected products are:
- SynchroMed II (Model No. 8637)
- SynchroMed EL (Model Nos. 8626 and 8627)
- Refill Kits (Model Nos. 8551, 8555, 8561, 8562, 8564, 8565 and 8566.
The federal agency is recommending that health care professionals check needle placement within the pump septum during the drug refill procedure. Medtronic is warning that it is essential that the needle be inserted through the refill septum until it has reached the needle stop in the pump reservoir. At every refill, patients and caregivers should be reminded about the signs and symptoms of drug overdose, underdose and withdrawal, the FDA said.
In the most recent warning about medications, the FDA said the SynchroMed II and SynchroMed El Implantable Drug Infusion Pumps contain and administer prescribed drugs or fluids to a specific site inside the patient's body.
Currently, the approved drugs for use with the SynchroMed Infusion Pump are Infumorp, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen.
These infusion pumps were manufactured from May 1998 through November 2012 and distributed from April 1999 through November 2012. Model numbers can be found in the recall notice.
The FDA recommends that in order to minimize the potential for motor stall, Medtronic recommends that health care professionals only use the approved drugs that are identified in the SynchroMed Infusion Pump labeling or drugs approved by FDA that are labeled for use with the SynchroMed II pump.
Health care professionals are warned not to use compounded drugs, unapproved concentrations, or unapproved formulations with the SynchroMed Infusion Pump.
FDA ANNOUNCES SHUTDOWN OF MEDICAL DEVICE COMPANY OVER WHEELCHAIR QUALITY, REPORTING PROBLEMS
Dec 20, 2012 The Food and Drug Administration announced today that medical device maker and distributor, Invacare Corp., and two of its top executives have signed a consent decree of a permanent injunction requiring the company to stop manufacturing, designing, and distributing manual and powered wheelchairs and wheelchair components.
The disciplinary action stems from the company and its executives failing to maintain quality manufacturing standards and failing to file complete adverse event reports that stem from customer and health care complaints about the products.
FDA officials said that once the consent decree is entered into a court record by a federal court judge Invacare will not be able to resume normal business operations at two of its Elyria, Ohio, facilities until it corrects all violations listed in the consent decree and it has been notified by the FDA that it is in compliance with the Federal Food, Drug, and Cosmetic Act (the Act).
The Act requires medical device companies to follow current good manufacturing practice and to follow strict guidelines in reporting adverse events to FDA.
Officials said that in order to comply with current good manufacturing practice, a medical device company must establish and follow specific procedures, which are outlined in FDA's Quality System regulations, to prevent quality problems in their devices.
the FDA said that seven FDA inspections of the Invacare facilities subject to the consent decree since 2002 have documented violations of FDA's Quality System regulations, along with failures to properly report adverse events to the agency.
"Medical device makers must produce high-quality products and report adverse events to FDA," said Steve Silverman, director, Office of Compliance, FDA's Center for Devices and Radiological Health. "Firms that fall short of our requirements risk FDA action to stop distribution of their products."
The consent decree also requires Invacare to retain a third-party expert to help it develop and submit plans to FDA to correct the violations found by the agency.
Once Invacare receives permission from FDA to resume manufacturing and distributing, the company must continue to submit audit reports to the agency for 5 years to verify continuing compliance. In addition to these audit inspections, the FDA will monitor the company's activities through its own inspections.
The parties filed the consent decree, which was signed by Gerald B. Blouch, Invacare's president and chief operating officer, and Ronald J. Clines, the company's director of Product Risk and Quality Engineering, in the United States District Court for the Northern District of Ohio on Dec. 20, 2012.
If the defendants violate the consent decree, then the FDA may order Invacare to cease manufacturing, recall products, and take other corrective action, and the agency may levy fines of up to $7 million annually.
The FDA is an agency within the U.S. Department of Health and Human Services charged with protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
FDA ISSUES ANOTHER DRUG SAFETY ALERT ABOUT PRADAXA SIDE EFFECTS, INCLUDING BLEEDING, STROKES, HEART ATTACKS
Dec 20, 2012 The Food and Drug Administration is continuing to issue warnings about dangerous side effects caused by the popular blood-thinner medication Pradaxa, which has been plagued by incidents of internal bleeding among patients.
In its most recent safety alert, the FDA announced that it is informing health care professionals and the public that Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots (major thromboembolic events) in patients with mechanical heart valves, also known as mechanical prosthetic heart valves.
The FDA said a clinical trial in Europe (the RE-ALIGN trial) was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users.
Pradaxa is not approved for patients with atrial fibrillation caused by heart valve problems. FDA is requiring a contraindication (a warning against use) of Pradaxa in patients with mechanical heart valves.
Pradaxa was marketed as a new-generation, safer alternative to the anticoagulant warfarin, which had long been one of the dominant blood-thinners on pharmacy shelves.
However, as many of 10 percent of Pradaxa users have been reported as suffering internal bleeding and in 2011 the FDA was forced to notify health care professionals and patients in a Drug Safety Communication that it was reviewing the increasing number of serious bleeding incidents involving dabigatran.
The problems with Pradaxa patients suffering from internal bleeding have generated a wave of Pradaxa lawsuits in state and federal courthouses across the country. Free consultations are now being offered by Pradaxa lawyers but there may be time limits affecting these cases so Pradaxa victims are urged to act immediately.
Was Pradaxa adequately tested?
Considering the number of Pradaxa lawsuits and warnings by the FDA about dangerous side effects from the medication some critics of the FDA are questioning whether the FDA and the drug's manufacturer conducted adequate testing of the drug before it was made available to patients. Victims in Pradaxa lawsuits say the manufacturer didn't.
Pradaxa is a blood-thinning medication used to reduce the risk of stroke and blood clots in patients with a specific condition called non-valvular atrial fibrillation (AF), a common heart rhythm abnormality that causes the upper chambers of the heart, or atria, to beat rapidly and irregularly. Pradaxa is not indicated for patients with atrial fibrillation caused by heart valve problems.
The FDA is recommending that health care professionals should promptly transition any patient with a mechanical heart valve who is taking Pradaxa to another medication.
The use of Pradaxa in patients with another type of valve replacement made of natural biological tissue, known as a bioprosthetic valves, has not been evaluated and cannot be recommended. Patients with all types of prosthetic heart valve replacements taking Pradaxa should talk to their health care professional as soon as possible to determine the most appropriate anticoagulation treatment.
The FDA said patients should not stop taking anticoagulant medications without guidance from their health care professional; stopping Pradaxa or other anticoagulants suddenly can increase the risk of blood clots and stroke.
The FDA is encouraging health care professionals and patients to report adverse events or side effects related to the use of Pradaxa to the FDA's MedWatch Safety Information and Adverse Event Reporting Program at the agency web site.
FDA issued earlier Pradaxa bleeding alert
On Aug. 2, 2012, the FDA informed health care professionals and patients that it was continuing to evaluate new data about the risk of serious bleeding associated with the use of the anticoagulants Pradaxa and warfarin, an older-generation anti-coagulant.
The FDA said that it does not appear that bleeding rates associated with new use of Pradaxa are higher than bleeding rates associated with new use of warfarin.
However, consumer advocates, medical researchers and Pradaxa attorneys who have filed Pradaxa internal bleeding lawsuits note that the FDA failed to note that there is no antidote for Pradaxa internal bleeding incidents.
The FDA also said that it is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.
LIVER FAILURE CONCERNS RAISED OVER QUALITEST
Dec 17, 2012 The Food and Drug Administration has announced that Qualitest, a subsidiary of Endo Health Solutions, has issued a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets over potentially oversized tablets that could lead to liver toxicity.
FDA officials said the USP 10 mg/500 mg. bottles from the affected lots may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended acetaminophen dose.
The FDA said unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen-containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day.
Acetaminophen is one of the most popular pain-killers on pharmacy shelves - Tylenol, for instance is as well-recognized as any other medication - but for some patients, however, it can also be one of the most dangerous. It is a little-known medical statistic that nearly half of all liver failures that occur in the United States are caused by victims ingesting acetaminophen - the active ingredient in Tylenol - in doses that are too powerful for their livers.
According to allegations contained in these Tylenol lawsuits, some of these overdoses occurred even though the victims were careful about following the recommendations made by Tylenol and other acetaminophen manufacturers about the proper dosages, particularly in the case of Extra Strength Tylenol. The two medications are at or near the top of top selling medications each year and are trusted and used by tens of millions of Americans.
In the Qualitest recall notice, the FDA said taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, for example other sedating medications or certain antidepressants.
FDA officials said hydrocodone bitartrate and acetaminophen 10mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.
The affected lots were distributed between Feb. 20, 2012 and Nov. 19, 2012 to wholesale distributors and retail pharmacies nationwide. The FDA is recommending that consumers who have the affected lots contact Qualitest. Consumers who are unsure if they have the affected lot numbers or have any concerns about their product should consult their pharmacy or health care professional.
FDA ISSUES CLASS 1 RECALL OF HEARTSINE DEFIBRILLATOR
Nov 20, 2012 The Food and Drug Administration has announced a Class 1 recall of the HeartSine Samaritan Public Access Defibrillator because the devices have been found to intermittently turn on and off, which could lead to life-threatening problems.
FDA officials said that HeartSine has notified customers that certain Samaritan 300/300P PAD devices have been found to have this problem, which may eventually deplete the battery in the units.
Also posing a separate problem, said the FDA, is that certain Samaritan 300/300P PAD devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery, resulting in the device turning itself off. A device experiencing either condition could be unable to deliver therapy during a cardiac event.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
HeartSine said that no deaths or injuries have been reported to date associated with the on/off issue but has received five reports of death for which the company has not been able to rule out the possibility that the events may have been related to the battery management software issue.
HeartSine officials identified the Samaritan 300/300P PAD devices manufactured and distributed from Aug. 1, 2004 to Jan. 31, 2011 with the following serial numbers as affected by this recall:
- 0400000501 to 0700032917
- 08A00035000 to 10A0070753
- 10C00200000 to 10C00210106
Samaritan 300/300P PAD devices are intended for use on patients experiencing sudden cardiac arrest.
The FDA said that HeartSine issued a letter to customers on Sept. 11, 2012 describing the problem and provided instructions for correction. HeartSine has requested that customers follow the instructions detailed in their letter dated Sept. 11, 2012 to ensure that affected devices are able to provide therapy if a sudden cardiac arrest event occurs.
The FDA is encouraging health care professionals and patients to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program on the agency web site.
HeartSine said that consumers with questions may contact the company at 1-877-877-0147 between the hours of 8:00am and 5:00 pm ET and email at email@example.com.
FDA REASSESSES PRADAXA, WARFARIN BLEEDING DANGERS
Nov 2, 2012 - The Food and Drug Administration has issued a public update of its assessment of the serious bleeding risks attached to best-selling blood thinners Pradaxa and warfarin and says data reviewed by the agency shows equal bleeding risks.
Both drugs are designed to help prevent heart attacks and strokes with Pradaxa being marketed as a newer, improved medication. However, both drugs have been the subject of numerous lawsuits in which victims claim that serious bleeding problems caused by the drugs have led to kidney, brain, gastrointestinal bleeding and heart attacks and deaths.
There have been so many Pradaxa lawsuits filed, for instance, that a huge number have been consolidated before a judge who is overseeing pre-trial evidence gathering and settlement talks.
The controversy has drawn the attention of USA TODAY, which recently profiled the Pradaxa litigation and noted that "The drug has been under attack by physicians groups and patient advocates since 3,781 adverse effects and 542 deaths associated with Pradaxa were reported last year to the Food and Drug Administration. Its adverse reports and deaths surpassed all other monitored drugs."
In its safety review, the FDA said it evaluated new information about the risk of serious bleeding associated with use of the anticoagulants (blood thinners) dabigatran (Pradaxa) and warfarin (Coumadin, Jantoven, and generics).
Officials said the assessment was done using insurance claims and administrative data from FDA’s Mini-Sentinel pilot of the Sentinel Initiative.
The results of this assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial).
The FDA said it will continue to evaluate multiple sources of data in the ongoing safety review of this issue. In doing so, officials noted the continued danger of bleeding problems:
"Pradaxa and warfarin are important medications used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation (AF), the most common heart rhythm abnormality, which causes the heart (upper chambers or atria) to beat rapidly and irregularly. Although these drugs reduce the number of strokes in patients with non-valvular AF, they can cause bleeding, potentially leading to serious or even fatal outcomes. The risk of bleeding is a well-recognized risk of anticoagulant drugs."
The FDA said in its announcement that it has not changed its recommendations regarding Pradaxa.
"Pradaxa provides an important health benefit when used as directed," the FDA said. "Health care professionals who prescribe Pradaxa should carefully follow the dosing recommendations in the drug label, especially for patients with renal impairment (when kidneys don’t function normally) to reduce the risk of bleeding. Patients with atrial fibrillation should not stop taking Pradaxa without first talking to their health care professional. Stopping use of anticoagulant medications such as Pradaxa can increase the risk of stroke. Strokes can lead to permanent disability and death."
Agency officials couched their announcement in terms that seemed to hedge on the safety of the drugs, such as in saying "at this time," and "is working to determine" and "continues to believe" while saying that the safety of the drugs is still being evaluated.
"FDA will communicate any new information on the risk of bleeding and Pradaxa when it becomes available," officials said.
The FDA also encouraged health care professionals and patients to report adverse events or side effects related to the use of these drugs to the agency's MedWatch Safety Information and Adverse Event Reporting Program.
CLASS 1 RECALL OF HOSPIRA SYMBIQ INFUSION SYSTEM TOUCHSCREENS ISSUED OVER LIFE-THREATENING RISKS
(Oct 31, 2012) The U.S. Food and Drug Administration has announced a Class 1 recall of Hospira Symbiq Infusion System touchscreens over problems that could lead to life-threatening conditions for patients.
The Symbiq infusion pump is a prescription device used to deliver controlled amounts of medications or other fluids to patients through intravenous, intra-arterial, epidural, and other acceptable routes of administration. The touchscreen is used to control infusion pump settings for patient therapy.
The FDA said the products are being recalled because the Symbiq pump touchscreen may not respond to user selection, may experience a delayed response or may register a different value from the value selected by the user.
Officials said that failure of the touchscreen to respond to user input could result in a delay or interruption in therapy or over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen before starting the infusion.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The FDA said health care providers experiencing this problem should remove the impacted device from use and contact their institution's biomedical or clinical engineering department to perform the touchscreen test described in the Symbiq technical service manual.
Officials said that if the biomedical or clinical engineering department identifies that the device is not working properly, they should contact Hospira Inc., 275 N Field Dr., Lake Forest, Illinois 60045-2579.
The FDA said an Urgent Device Correction letter notifying customers of this recall was mailed by Stericycle, Inc, on behalf of Hospira on August 29, 2012.
Customers were instructed not to return affected Symbiq infusion pumps. In addition, the letter lists steps that users may take to confirm that infusion settings are correctly entered as well instructions for how to stop an infusion.
The FDA said that customers were also instructed to complete and return a reply card that was included with the letter, to indicate the number of infusion systems at their facility and whether clinicians throughout the facility had been notified of the touchscreen issue. Wholesalers were asked to notify their customers.
Hospira officials said they have determined that the touchscreen issue is related to software and the company is developing design improvements to correct it. Once the design and development activities are complete, Hospira will notify customers.
The FDA said health care professionals and consumers should report adverse reactions or quality problems they experienced using these products to the FDA through the agency's web site.
The affected models and serial numbers are 16026 Symbiq One Channel Infuser and 16027 Symbiq Two Channel Infuser.
FDA'S ACTOS BLADDER CANCER WARNING CAME TOO LATE FOR SOME PATIENTS
(Oct 31, 2012) John Faique of North Carolina began taking Actos in 2007 in an effort to control his Type 2 diabetes. After trusting the medication for three years he was diagnosed with bladder cancer in 2010 and died a month later, according to court documents.
Seven months after Faique's death, the U.S. Food and Drug Administration issued a public announcement directed at consumers and health care professionals warning about an established link between Actos and bladder cancer.
In its health warning the FDA said that "use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.
The FDA's confirmation of the risks of Actos bladder cancer came too late for Faique as it has for many other Actos victims who have developed bladder cancer as a result of their trust in the drug.
Now, Faique's widow, Norma Faique, has joined the list of people who have filed an Actos bladder cancer lawsuit, seeking compensation from the drug's manufacturer, Asian drug giant Takeda Pharmaceuticals.
As in the overwhelming number of Actos lawsuits, Faique's widow claims that Takeda failed to inform her husband, other Actos patients, physicians and the FDA about this dangerous side effect.
A review of court dockets across the country shows that Actos lawsuits are being filed on a daily basis over the same allegations. There is already such a large amount of cases that many are being consolidated before a single judge as Actos victims seek what legal experts say may be billions of dollars in damages to be paid out in settlements and jury awards.
The warning flags about the dangers of Actos have long been waved:
- Actos lawsuits have been filed for several years by patients who claim their bladder cancer was caused by the medication.
- The FDA has issued safety warnings about the drug citing the increased risk of bladder cancer and issued updated drug label warnings and recommendations for physicians over the link to bladder cancer.
- The FDA later issued an even stronger warning that use of Actos for more than a year was not being recommended because of the link to bladder cancer.
- Even before the FDA's safety warning, the consumer advocacy group Public Citizen slapped a "Do Not Use" warning on the medication "because its many risks do not outweigh its benefits" and safer diabetes drugs are available.
- Public health officials in both Germany and France have either suspended sales of Actos or recommended that no new patients be treated with the drugs.
FDA officials said the Actos warning came after a review of data complied half way through a 10-year study of 193,099 diabetes patients in which researchers said that patients who used Actos for longer than 12 months had a 40 percent increased risk of developing bladder cancer over patients who did not use the medication.
With all of this as a backdrop, John Faique's survivors must also be dismayed to learn that the FDA has refused calls to ban Actos while Takeda is still making huge profits from the sale of the medication. The company reported that about 25 percent of its 2011 revenue came from Actos sales.
STRYKER NEPTUNE PRODUCTS SUBJECT OF FDA
CLASS 1 RECALL AFTER AT LEAST ONE DEATH REPORTED
(Oct. 26, 2012) The Food and Drug Administration has announced a Class 1 recall of some Stryker Neptune Rover Waste Management Systems models after receiving a report of at least one death from tissue damage caused by the product.
The FDA said it has notified health care professionals of the problems involved with Stryker’s Neptune 1 Silver and Neptune 2 Ultra Waste Management Systems. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
FDA and Stryker officials said they have received one report of serious injury and one report of death as a result of tissue damage resulting from use of the product.
They said that the patient death and injury reports indicate that the high-flow, high-suction vacuum had been incorrectly applied, and that the instructions for use on the device did not specifically warn against this action. When used incorrectly, the Neptune 1 Silver and the Neptune 2 Ultra can cause hemorrhaging and soft tissue, muscle, and vital organ damage that can lead to serious injury and/or death.
The FDA said the Neptune 1 Silver Waste Management System (Neptune Silver) and the Neptune 2 Ultra Waste Management System (Neptune 2 Ultra) are intended to collect and dispose of surgical fluid waste in operating rooms and surgical facilities.
The Neptune 2 Ultra can also remove smoke generated at surgical sites by electrocautery or laser devices. Both systems consist of a mobile rover unit that can be relocated to a waste disposal area so the waste collection canisters can be emptied through the device’s docking station.
The FDA is recommending that health care providers NOT use the Neptune 1 Silver Waste Management System or the Neptune 2 Ultra Waste Management System unless there is no alternative suction device or waste management system available.
Officials said professionals should evaluate the risks and benefits of using the Neptune 1 Silver or the Neptune 2 Ultra and unless a facility does not have an alternative means for surgical waste disposal during surgery, a Certificate of Medical Necessity must be completed and sent back to Stryker.
The FDA also is encouraging health care professionals and patients to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
These products were manufactured from February 2001 through April 6, 2012 and distributed from March 26, 2001 through April 6, 2012.
ACCUTRON ANNOUNCES NATIONAL RECALL OF FLOWMETERS OVER LIFE-THREATENING NITROUS OXIDE CONCERNS
(OCT. 16, 2012) The U.S. Food and Drug Administration has announced that Accutron, Inc. is conduction a nationwide Class 1 recall of its Ultra PC% Cabinet Mount Flowmeters for Nitrous Oxide-Oxygen Sedation Systems because of complaints about possible life-threatening problems.
The FDA said Accutron agreed to voluntarily recall the product after learning through two customer complaints that the flowmeter was flowing nitrous oxide gas without any oxygen gas flow. When not mixed with oxygen, inhaling nitrous oxide can lead to temporary and permanent brain damage and death.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The Ultra PC% flowmeter is used to control the flow of gases used in nitrous oxide-oxygen sedation systems. Nitrous oxide-oxygen sedation systems are used to sedate patients during certain dental procedures. The company has reported that two complaints have been received for this flowmeter defect, however, no injuries have been reported to date.
The FDA is recommending that consumers with the affected flowmeters stop using them and return the flowmeters to Accutron for a free replacement. The company notified distributors and customers of this recall by mail and is arranging for return and replacement of all recalled products.
The FDA is also encouraging health care professionals and patients to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program at the agency web site.
Accutron officials said the affected units were manufactured from November 2009 to April 2009 and distributed from November 26, 2008.
FDA ISSUES WARNING ABOUT SERIOUS BURN RISK FROM OVER-THE-COUNTER MUSCLE AND JOINT PAIN RELIEVERS
(SEPT. 18, 2012) The U.S. Food and Drug Administration has issued a health alert warning consumers and health care professionals that certain over-the-counter (OTC) products that are applied to the skin for the relief of mild muscle and joint pain have been reported to cause serious skin injuries, ranging from first- to third-degree chemical burns, where the products were applied.
FDA officials said that when applied to the skin, the products produce a local sensation of warmth or coolness but that these products should not cause pain or skin damage. However, officials said, there have been cases of serious burns following their use. Some of the burns had serious complications requiring hospitalization
OTC topical muscle and joint pain relievers are used to temporarily relieve minor muscle and joint aches and pain. These OTC topical muscle and joint pain relievers are available as single- or combination-ingredient products that contain menthol, methyl salicylate, or capsaicin, and are marketed under various brand-names, such as, Bengay, Capzasin, Flexall, Icy Hot, and Mentholatum. The various formulations include creams, lotions, ointments, and patches.
The FDA said that if you've ever rubbed a topical pain reliever—a cream, gel or other product applied to the skin—on a sore muscle or joint, you're familiar with the sensation of warmth or coolness that soon follows. But if, instead, you experience burning pain or blistering, you must seek medical attention immediately.
FDA officials said that in many cases, burns where the product was applied occurred after just one application, with severe burning or blistering occurring within 24 hours. Some had complications serious enough to require hospitalization.
"There's no way to predict who will have this kind of reaction to a topical pain reliever for muscles and joints," says Dr. Jane Filie, a medical officer in the FDA's Division of Nonprescription Regulation Development.
According to FDA chemist Reynold Tan, Ph.D., there have been 43 reported cases of burns associated with the use of OTC topical muscle and joint pain relievers containing the active ingredients menthol, methyl salicylate and capsaicin. These cases were uncovered by FDA scientists during safety surveillance of FDA's adverse event reporting database and the medical literature.
This is a very small number of cases when compared to the number of people who purchase these products, Tan notes.
According to the available data, a majority of the more severe burns occurred with the use of a menthol or menthol/methyl salicylate combination product. Most of these cases involved products that contain higher concentrations of menthol and methyl salicylate (greater than 3% menthol or 10% methyl salicylate).
Safety Do's and Don'ts
The FDA issued the following advice for consumers using OTC topical muscle and joint pain relievers:
- Don't apply these products onto damaged or irritated skin.
- Don't apply bandages to the area where you've applied a topical muscle and joint pain reliever.
- Don't apply heat to the area in the form of heating pads, hot water bottles or lamps. Doing so increases the risk of serious burns.
- Don't allow these products to come in contact with eyes and mucous membranes (such as the skin inside your nose, mouth or genitals).
- It's normal for these products to produce a warming or cooling sensation where you've applied them. But if you feel actual pain after applying them, look for signs of blistering or burning. If you see any of these signs, stop using the product and seek medical attention.
- If you have any concerns about using one of these products, talk to a medical professional first.
- Report unexpected side effects from the use of OTC topical pain reliever to the FDA MedWatch program.
FDA ANNOUNCES CLASS 1 RECALL OF I-FLOW ON-Q PUMPS OVER LIFE-THREATENING RISKS
(AUG. 31, 2012) -- The Food and Drug Administration has announced a Class 1 recall of I-Flow ON-Q Pumps with an ONDEMAND Bolus Button because of flow problems that may be life-threatening.
FDA officials said they have notified health care professionals that the I-Flow's Bolus Button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowest most position.
The FDA said that when this occurs, the patient may receive continuous infusion at a rate greater than expected. As a result, this product may cause serious adverse health consequences, including death.
The On-Q pump with ONDEMAND bolus button is used for continuous and intermittent delivery of medicines (such as local anesthetics or narcotics) to or around surgical wound sites and/or to nearby nerves for pre-operative, during the procedure/surgery (perioperative), and for post-operative regional anesthetic and pain management.
The FDA said that on May 8, 2012, the firm sent an IMPORTANT VOLUNTARY RECALL NOTICE to its customers who purchased the ON-Q pump with ONDEMAND bolus button. Customers should identify all affected products within your inventory and quarantine the affected products.
The FDA is encouraging health care professionals and patients to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program on the agency's web site.
The I-Flow ON-Q pump with ONDEMAND bolus button was manufactured from October 18, 2002 through April 30, 2012 and distributed from May 3, 2010 through May 1, 2012. The affected product numbers are listed on the recall notice. The recalling firm is the I-Flow Corporation, 20202 Windrow Drive, Lake Forest, California 92630.
DIETARY SUPPLEMENT EPHBURN 25 RECALLED OVER EPHEDRINE HEALTH RISKS
(AUG. 31 2012) – The Food and Drug Administration has announced that Brand New Energy (BNE), a dietary supplement re-sale distributor, is recalling all lot codes of EphBurn 25 because of life-threatening ephedrine alkaloid ingredients.
Officials said the recall was initiated on Aug. 28, 2012, after notification by the FDA to a third-party retailer which purchased EphBurn 25 that one lot of EphBurn 25 was sampled by the FDA and found to contain ephedrine alkaloids, making it an unapproved drug.
Ephedrine is commonly used as a stimulant, appetite suppressant, concentration aid, and decongestant, and it has been used to help aid in weight loss. The ephedrine alkaloids work mainly by increasing the activity of noradrenaline on adrenergic receptors.
A number of adverse effects associated with ephedrine alkaloid-containing dietary supplements have been reported to the FDA. These include elevated blood pressure, rapid heartbeat, nerve damage, muscle injury, and psychosis and memory loss. More serious effects have also been reported, including heart attack, stroke, seizure and death, the FDA said.
Agency officials said that the company has not reported any adverse events associated with this recalled product.
This recall affects all lot codes and use by dates of EphBurn 25. The product is a 90-count bottle with red capsules and prominently displays the product name "ephBURN 25" in white letters on the front of a red label. There is no UPC code. EphBurn 25 was previously discontinued on or about May of 2012.
BNE is a reseller of nationally-known diet and energy supplements such as Zantrex 3, Trim Spa, Hydroxy Cut and others. The product subject to recall, EphBurn 25, was distributed to various retail stores nationwide, and the product was sold via the Internet from the period of time of approximately April 2010 through August 2012. No other products distributed by BNE are subject to recall.
The FDA said consumers who may have purchased EphBurn 25 should immediately discontinue using the product and contact their health care professional if they have experienced any adverse effects. Consumers can contact the distributor of the product at firstname.lastname@example.org or call 1-888-234-2595 (8 a.m. to 4 p.m. PST) to receive further instructions for returning the product or with any questions.
BNE officials released a statement saying the company regrets any inconvenience to consumers and the recall has been taken voluntarily out of concern for the health and safety of consumers.
The FDA said adverse reactions or quality problems experienced with the use of this product may be reported to the agency's MedWatch Adverse Event Reporting program online, by regular mail, or by fax.
FDA WARNS AGAINST REVATIO USE IN CHILDREN
(AUG. 31, 2012) – The Food and Drug Administration has issued a drug warning notifying health care professionals and their medical care organizations that Revatio (sildenafil) should not be prescribed to children (ages 1 through 17) for pulmonary arterial hypertension (PAH).
The FDA said its recommendation against use is based on a recent long-term clinical pediatric trial showing that children taking a high dose of Revatio had a higher risk of death than children taking a low dose. Officials also said the low doses of Revatio are not effective in improving exercise ability.
Officials said treatment of PAH in children with this drug is an off-label use not approved by FDA and a new warning, stating the use of Revatio is not recommended in pediatric patients has been added to the Revatio labeling.
Revatio is a phosphodiesterase-5 inhibitor used to treat pulmonary arterial hypertension by relaxing the blood vessels in the lungs to reduce blood pressure and is approved to improve exercise ability and delay clinical worsening of PAH in adult patients.
The FDA is recommending that patients and caregivers not change the Revatio dose or stop taking Revatio without talking to a health care professional. Health care professionals were reminded that use of this product, particularly chronic use, in children is an off-label indication, not approved by FDA, and is not recommended.
The warning came after analysis of the data summary from the randomized, double-blind, placebo-controlled clinical trial of 234 patients with PAH, 1 to 17 years of age with mild to moderate symptoms at baseline, the FDA said.
FDA ANNOUNCES CLASS 1 RECALL OF BAXTER NUTRITION COMPOUNDERS OVER ELECTICAL FAILURE CONCERNS
(AUG. 29, 2012) – The Food and Drug Administration has announced that Baxter Healthcare Corp. is conducting a Class 1 recall of the company's Automix Automated Nutrition Compounder Systems because of possible life-threatening electrical failures.
FDA officials said that they have issued notifications to health care professionals about the recall. The problem, officials said, can be caused by incorrect key press responses, caused by fluid entry into device keypads, and intermittent electrical failures.
Fluids, such as water, cleaning solutions, and nutrition source solutions, may enter into the keypad of the Automix control module and may cause the Automix to generate an incorrect device response to an Automix operator's key press, officials said.
The intermittent electrical failures may cause the motors on the Automix to pump nutrition solution when not programmed to do so, or may cause the Automix to stop compounding before it has finished appropriately mixing the Total Parenteral Nutrition (TPN) Solution. Causes for the intermittent electrical failures have not been determined.
The FDA said the incorrect key response failure and the intermittent electrical failures may lead to improperly mixed TPN solutions (e.g. incorrect volumes, incorrect solutions, and/or solution incompatibilities). For critical components of TPN, such as Potassium Chloride and Calcium Chloride, large variations in dosing in highly vulnerable patients could lead to serious injury and/or death, officials said.
Baxter Healthcare Corp. Automix Compounder Systems are automated nutrition compounders that use weight-based (gravimetric) measuring, often controlled by software, to provide compounding of total parenteral nutrition (TPN) solutions to a patient.
The FDA is recommending that customers discontinue using the Automix compounder and transition to an alternative option as soon as possible.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
FDA ANNOUNCES NATIONWIDE RECALL OF REUMOFAN PLUS OVER LIFE-THREATENING REACTION FEARS
(AUG, 24, 2012) – The Food and Drug Administration announced today that Samantha Lynn Inc. has issued a voluntary recall of numerous lots of Reumofan Plus Tablets because of the discovery of ingredients that could lead to life-threatening reactions in patients.
FDA officials said 500 lots are being recalled across the nations because of findings that the medications contain undeclared drug ingredients. Consumers that have Reumofan Plus should be aware that the product may pose a health risk and are advised to consult their family doctor/stop using/return to place of purchase or discard the product.
Officials said an agency sample analysis has found the product to contain methocarbamol and diclofenac. Use of this product could result in life-threatening hypersensitivity reactions and anaphylaxis and could cause a temporary and reversible increase in CNS depression, officials said. The FDA said that Samantha Lynn Inc. officials told them the company has not received any reports of adverse events related to this recall.
The product is used as a treatment for muscle pain, arthritis, osteoporosis, bone cancer and other conditions. The affected Reumofan Plus lots may include the following lot number(s): 99515 ex096 and expires: 2016. The product is marketed in a green bottle containing 30 lavender round tablets and is distributed nationwide via the internet.
The FDA said that if you purchased Reumofan Plus from Samantha Lynn Inc. between Feb 2012 and June 2012, you will receive an email shortly notifying you of your options. If you purchased Reumofan Plus from elsewhere, the FDA said, do not contact Samantha Lynn Inc. Contact your local FDA office.
The FDA said consumers with questions regarding this recall can contact Samantha Lynn Inc. by e-mail to email@example.com Monday - Friday between 8 a.m. to 5 p.m., Pacific Standard Time. Consumers should contact their physician or health care provider if they have any health questions or have experienced any problems that may be related to taking or using this product, the FDA said.
Officials said adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
NEW HEALTH RISK FROM USE OF STATINS: CATARACTS
(AUG. 27, 2012) Another health risk has been linked to the use of statin, the widely popular prescription drugs that millions of people use to control their levels of cholesterol. A new study shows that there is link between the use of the drugs and the risk of developing cataracts.
The news is the latest dangerous side effect that have been attributed to this class of drugs that includes some of the most widely known and best selling medications, including Lipitor, Pravachol, Crestor, Zocor, Lescol and Vytorin.
Medical researchers in earlier reported findings have attributed other serious health issues such as diabetes or cardiac problems to the use of these drugs even as they become among the most widely sold prescriptions around the world to the large number of patients who are suffering from high cholesterol.
The findings were reported on the National Health Institutes' Health Day News web site in a report analyzing the findings published in the August issue of the journal Optometry and Vision Science.
The analysis said that the new research indicates that the bump in cataract risk linked to statin use appears comparable to the elevated risk already known to exist among people with type 2 diabetes:
"The bottom line is that there appears to be an increased risk among people taking statins as far as getting cataracts," said study lead author Elizabeth Irving, research chairwoman in the School of Optometry and Vision Science at the University of Waterloo in Ontario, Canada. "That was actually a surprise, because most of the previous literature had suggested the opposite. However, it doesn't mean that one is causing the other."
"I would also say we are not now suggesting that statin patients do anything except follow their doctor's advice with respect to statins," Irving added. "They're taking statins for a reason. If you're going to have a heart attack or get cataracts, what would you choose?"
Health Day said the authors of the findings noted that previous animal research has already pointed to a possible link between high-dosage statin use and a bump in the risk for cataracts, which are characterized by a significant clouding of the eyes' lenses.
To explore the potential link between statins and eye health in humans, the investigators focused on nearly 6,400 cataract patients who were being treated at the University of Waterloo between 2007 and 2008, according to the report, which said that of those patients, more than 450 had type 2 diabetes, and both diabetes status and statin use were looked at possible risk factors for cataracts.
"After accounting for factors such as gender, cigarette use and high blood pressure, the team found that statin use was associated with a 57 percent increased risk for developing cataracts.
Statin users were more likely to develop cataracts at a younger age, the study found. For patients without diabetes, the average age for which the odds of developing cataracts were at least 50 percent was 57.3 years for those not using statins compared with 54.9 years for those taking statins. Patients with diabetes had the same cataract risk at 55.1 years if not using statins and 51.7 years if taking them.
Some overlap existed between diabetes and statin use, the team noted, with 56 percent of the diabetic cataract patients regularly taking statins. The authors pointed out that patients with diabetes who also took statins were found to have developed cataracts a full 5.6 years earlier than those who neither had diabetes nor took statins.
Yet the team nevertheless determined that statin use appeared to be, by itself, an independent risk factor for cataracts."
The authors of the report said that the findings do not mean that people should discontinue using statins but that they should be aware of the side effects that could be caused by their use.
Other recent medical research also has questioned the safety of the use of statins. In addition to cataracts, diabetes and cardiac problems, a recent study conducted by researchers at the University of California at San Diego found that patients participating in that review suffered fatigue, loss of energy and exercise problems while taking the medications.
"The medical community needs to spend more time asking whether the benefits of these drugs outweigh the risks for certain patients," said Beatrice Golomb, a professor of medicine at the university's School of Medicine and the study's author in an interview with U-T San Diego.
"Those placed on statins were significantly more likely than those on placebo to report worsening in energy, fatigue-with-exertion or both," Golomb told the newspaper. "Both statins contributed to the finding though the effect appeared to be stronger in those on simvastatin (a drug that led to greater cholesterol reduction.)"
FDA ISSUES NEW SAFETY COMMUNICATION ABOUT USE OF STRYKER STENTS TO REOPEN NARROWED ARTERIES
(AUG. 27, 2012)The Food and Drug Administration has issued a new Safety Communication recommending new limitations involving the type of intracranial stenosis patients on whom Stryker Wingspan Stent Systems may be used.
FDA officials said data collected in clinical studies show that Wingspan may present unacceptable risks, such as stroke and death, to many patients previously considered appropriate for treatment with Wingspan.
The FDA said the Wingspan is used to open narrowed arteries in the brains of patients diagnosed with intracranial stenosis who are experiencing repeated strokes. Stenosis, or narrowing of the intracranial arteries, is a serious condition caused by a buildup of plaque within the arteries, and there are few treatment options available for managing this condition.
Patients with intracranial stenosis are at serious risk of life-threatening strokes due to reduced blood flow to the brain from narrowed or blocked arteries. The Wingspan stent is intended to reopen narrowed arteries in certain patients to potentially prevent additional strokes.
The FDA approved Wingspan in 2005 as a Humanitarian Use Device (HDE) for patients with treatment-resistant (refractory) intracranial atherosclerotic disease who have 50 percent or greater narrowing in the intracranial arteries. HDE devices are intended to treat or diagnose a disease or condition that affects fewer than 4,000 people in the United States per year.
The FDA said it issued this communication to inform health care providers and patients that the indications for use and labeling for the Wingspan stent have changed to limit the use of Wingspan to a narrow, select group of patients and conditions. These changes are based on analysis of the original HDE clinical study, data from studies performed after the HDE approval was granted, and data from a clinical trial called the Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study.
After reviewing the available safety information, the FDA believes that a very specific group of patients with severe intracranial stenosis and recurrent stroke despite continued medical management - who have not had any new symptoms of stroke within the seven days prior to planned treatment with Wingspan - may benefit from the use of the device. The agency's assessment of benefits and risks for this device considered that these patients are at serious risk of life-threatening stroke and have limited alternative treatment options.
Wingspan is now approved only for patients who are between 22 and 80 years old AND who meet ALL of the following criteria:
- who have had two or more strokes despite aggressive medical management;
- whose most recent stroke occurred more than seven days prior to planned treatment with Wingspan;
- who have 70-99 percent stenosis due to atherosclerosis of the intracranial artery related to the recurrent strokes; and
- who have made good recovery from previous stroke and have a modified Rankin score of 3 or less prior to Wingspan treatment. The Rankin scale is used to measure the degree of disability in stroke patients. Lower scores indicate less disability.
The Wingspan Stent System should not be used for:
- the treatment of stroke with an onset of symptoms within seven days or less of treatment; or
- for the treatment of transient ischemic attacks (TIAs).
FDA officials said that while Wingspan is not beneficial for the broad population of stroke patients studied in SAMMPRIS, there is evidence from the original HDE study to show there are probable benefits of using Wingspan to treat the specific population of patients outlined in the new indications for use.
The FDA said the manufacturer will be changing the physician and patient labeling for Wingspan to reflect the new indications for use. The new labeling also includes new contraindications, warnings and precautions and updated risk and benefit information.
Physicians should expect to receive the new labeling from Stryker and see this labeling in future Wingspan packaging.
The FDA is informing physicians that they should be aware that the Wingspan Stent System is approved by the FDA as a Humanitarian Use Device. Generally, a patient may be treated with Wingspan only if its use has been approved in advance by the treating physician's Institutional Review Board (IRB). The physician is responsible for obtaining IRB approval before Wingspan is administered to or implanted in a patient.
The FDA said it will continue to monitor and evaluate adverse events associated with Wingspan and also monitor the results of ongoing follow-up of patients from the SAMMPRIS study. The agency will make available any new information that might affect its use.
In addition, the FDA is requiring Stryker to conduct a post-market surveillance study (522 study) The FDA said it intends to share the data, when it becomes available.
FDA ANNOUNCES PROTICA RECALL OF NUTRITIONAL PRODUCTS OVER POSSIBLE HEALTH RISKS
(Aug. 23, 2012) – The Food and Drug Administration announced today that Protica Inc. is voluntarily recalling several of its nutritional products because of health concerns that could, in some cases, lead to life-threatening illnesses.
FDA officials said that Protica, of Whitehall, Pennsylvania, on Aug. 17, 2012, began what was described as a voluntary product withdrawal of four products. They include Body Choice "Protein Shots," Nutritional Resources "Protein Wave," ProBalance "Protein-to-Go French Vanilla Latte" and "Protein-to-Go Milk Chocolate Shake" because they have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death.
The FDA said Protica is warning consumers not to use the product even if it does not look or smell spoiled. Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms.
FDA officials said people experiencing these problems should seek immediate medical attention. Protica officials said that no illnesses connected with the products had been reported so far, according to the FDA.
The problems with the affected products, which were manufactured between Sept. 8, 2011 and June 8, 2012, were discovered when investigating the processing parameters for all manufactured products, the FDA said.
Protica officials said the products withdrawn were distributed nationally through retail and direct mail and are limited to specific lots of the branded products.
The FDA said Protica is informing consumers who have purchased any of the above products that they can be returned to the place of purchase or to Protica for a full refund. Consumers with any questions should contact Protica at 1-800-PROTICA (1-800-776-8422).
Protica, founded in 2001, is headquartered in Whitehall, PA. The company relocated from Horsham, Pa., to the Lehigh Valley in January 2009, occupying and rehabilitating the former vacant Lehigh Valley Dairy Plant near Allentown. Protica has approximately 60 employees and is privately held.
The recall announcement by the FDA was released from its headquarters in Silver Spring, Md.
SMITHS MEDICAL MEDFUSION PUMPS SUBJECT OF CLASS 1 RECALL DUE TO LIFE-THREATENING RISKS
(AUG. 23, 2012) The Food and Drug Administration has announced a Class 1 recall of certain models of Smiths Medical Medfusion Model 4000 Syringe Infusion Pumps because of problems that could be life-threatening for patients.
The FDA said that system errors can cause the Medfusion 4000 infusion pump to go into an alarm condition and stop running, which can result in a delay or an interruption of patient therapy. For patients receiving critical therapy, such as vasopressors, a delay or interruption of therapy could result in serious injury and/or death, according to the announcement. The FDA said that Smiths has not received any reports of patient injury or death to date due to this problem.
The Medfusion 4000 is a wireless, electronic infusion pump used to provide intravenous (IV) infusions of fluids, medications, blood, and blood products to adult, pediatric, and neonatal patients.
The recall involves all Model 4000 Syringe Pumps with Software Versions V1.0 and V1.1. The serial numbers are available on the FDA's web site and the reorder numbers are: 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78.
The FDA said the affected pumps were distributed from September 10, 2010, to February 3, 2012 and that Smiths initiated the recall on February 14, 2012
Customers with questions about this recall may contact Smiths Medical Customer Support at 1-800-258-5361, Monday through Friday, 8:00am to 8:00pm, EST.
The FDA said that on February 14, 2012, consignees of Medfusion 4000 Syringe Pumps with software versions 1.0 and 1.1 were visited by a Smiths Medical representative who informed them that their pumps required a software upgrade. These software upgrades were completed on February 15, 2012 for U.S. customers. Upgrades for Canadian customers are ongoing.
The FDA is encouraging health care professionals and consumers to report adverse reactions or quality problems they experienced using these products to the FDA's MedWatch reporting program on the agency web site.
COLORADO MAN SENTENCED TO 4-YEAR PRISON TERM FOR ASBESTOS VIOLATIONS, HIRING VULNERABLE HOMELESS WORKERS
(AUG. 23, 2012) In a case that authorities said was driven by "pure greed," a Colorado man was sentenced to four years in federal prison on his conviction for eight felonies stemming from the illegal demolition of a house in which homeless workers were hired and exposed to the dangers of toxic asbestos.
Attorney General John Suthers announced that a Pueblo County District Court judge sentenced Thomas K. Tienda to four years in the Department of Corrections after his demolition of a Pueblo house led to the airborne release of asbestos. The sentencing came after Tienda was convicted by a Pueblo jury.
"Sheer greed drove Tienda to cut costs at the expense of the public and jeopardized the health of vulnerable members of our society, the homeless," said Suthers. "A four-year prison sentence is appropriate and proves that this type of unscrupulous behavior will not go unpunished."
Asbestos is a toxic material that was widely used in insulation, roofing, flooring and other uses in buildings constructed before strict, new laws were passed regulating its use in the 1970s. Exposure to asbestos can cause several deadly diseases, most commonly malignant mesothelioma, an aggressive cancer for which there is no cure.
Mesothelioma develops after victims inhale airborne asbestos fibers that work their way into the linings of a victim's lungs, heart or abdominal organs and, over several decades, generate cancer cells which form tumors or spread to other parts of the body.
Suthers said that instead of hiring properly licensed contractors to safely demolish a multi-family house, Tienda hired homeless individuals and handymen to remove asbestos-containing materials to save money. Mr. Tienda hid the fact that his building contained asbestos from all of his workers, he said.
The attorney general's office said the demolition work, which also lacked the proper permit from the City of Pueblo, resulted in the release of asbestos into the air and that, in addition to intentionally exposing his workers to asbestos, Tienda's conviction also stemmed from reusing some of the asbestos-contaminated materials from the demolition as fill for potholes at his other properties.
"There is no safe level of exposure to asbestos," said Jeff Martinez, Acting Special Agent in Charge of EPA's criminal enforcement program in Colorado. "The defendant not only employed unsafe asbestos removal practices, he also tried to cover up his illegal actions. This sentence should send a clear message that the EPA will continue working closely with our state enforcement partners to prosecute those who violate the law and place their private gains over the public's well being."
In sentencing Tienda to the prison term the federal judge noted the vulnerability of the homeless workers who were hired on the project. Whether their exposure to the asbestos will cause any of them develop an asbestos-related disease will not be known for many years because most of the diseases have a long latency period – usually several decades – from the time the fibers are inhaled to the time that the diseases advance to the stage of becoming symptomatic. Homeless advocates in the area also decried Tienda's actions in exposing innocent victims to asbestos.
Environmental laws require that renovations or demolitions of structures containing asbestos follow strict rules and regulations in which certified asbestos removal experts are employed. These contractors must use fully trained and specially equipped workers who comply with federal asbestos-removal standards.
In addition to taking special measures to protect workers, these contractors also are required to obey strict safety standards in the removal and disposal of asbestos in order to safeguard against public exposure to the toxins.
The case was investigated by the Office of the Attorney General with the assistance of the Colorado Environmental Crime Task Force, the Air Quality Unit of the Colorado Department of Public Health and Environment, and the Environmental Protection Agency's Criminal Investigations Division.
Charges were filed against Tienda and the case was prosecuted by the Attorney General and the Pueblo District Attorney.
FDA ANNOUNCES CLASS 1 CAREFUSION PUMPS RECALL
(AUG. 21, 2012) – The Food and Drug Administration announced today that San Diego-based CareFusion has initiated a Class 1 recall of one of its medical devices because of problems with some units that could become life-threatening.
The FDA said the recall was made because there is a potential risk that the pump module door keypad overlay may separate from the keypad assembly. This product may cause serious adverse health consequences, including death, according to the FDA announcement.
The recall, which the FDA said the company initiated June 15, involves the CareFusion 303, Alaris Pump Module, Model 8100, which was formerly the Medley Pump Module manufactured between October, 2011 and February, 2012.
The FDA said the pump module is intended for health care facilities that use infusion for the delivery of fluids, drugs, blood, and blood products using continuous or intermittent delivery through intravenous, intra-arterial, subcutaneous, epidural, enteral, or irrigation of fluid spaces routes of administration. The pump module is used for adults, children, and newborns.
The recall is the latest for CareFusion, which initiated a recall of its EnVe ventilator in June because of the possibility of the product compromising patient ventilation and a voluntary recall of its AirLife Infant Breathing Circuit in May.
The FDA said that starting on July 20, 2102, each affected CareFusion customer and distributor received an URGENT: Medical Device Recall Notification letter, FAQs, Summary of Affected Units and Response Card by overnight courier service delivered upon signed receipt
The Recall Notification letter identified the problem and the action to be taken, officials said.
The FDA said CareFusion identified the potential problem when the pump module door keypad overlay was loose, peeled away, or separated from the door assembly. This could cause a potential for fluid ingress which could lead to a keypad malfunction causing the infusion to stop with alarm. When infusion stops, it could result in serious injury or death.
CareFusion customers were asked to visually examine the pump module keypad overlay for obvious signs of overlay separation. (See photo of an example of a separating keypad overlay in link below by locating CareFusion's URGENT: Medical Device Recall Notification letter. The problem may look different on different pump modules).
CareFusion informed customers that they will contact their facility by phone within 60 days of receiving the letter to schedule a visit to replace the door assembly on their affected pump module, according to the announcement.
Customers with recall-related questions were instructed to contact CareFusion Support Center at 1-888-562-6018. Customers with questions about adverse event reports were instructed to contact Customer Advocacy at 1-800-854-7128.
The FDA said health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the agency's MedWatch program.
FDA UPDATES DANGERS OF REUMOFAN SUPPLEMENTS
(AUG. 21, 2012) -- The Food and Drug Administration has issued an updated alert warning consumers that Reumofan Plus and Reumofan Plus Premium supplements contain undeclared active ingredients found in prescription drugs that should be used only under the supervision of a health care professional.
Since June 1, 2012, when FDA first warned the public about the dangers of these supplements, the agency has received reports of fatalities, stroke, severe bleeding in the gastrointestinal tract, dizziness, insomnia, high blood sugar levels and problems with liver and kidney functions, as well as corticosteroid withdrawal syndrome
FDA officials said that because of the possible risks, consumers should not buy or start using these products.
The FDA said Reumofan Plus, marketed as a natural dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful.
An FDA laboratory analysis of Reumofan Plus found that it contains Diclofenac Sodium, a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of the stomach and intestines, and Methocarbamol, a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.
The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant.
The FDA said it has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose control, weight gain, swelling, leg cramps, and adrenal suppression.
Reumofan Plus is marketed as a natural dietary supplement for pain relief. Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product.
The FDA is urging consumers who are currently taking or who recently stopped taking Reumofan Plus to consult a health care professional immediately.
Health care professionals are urged to ask their patients about use of Reumofan Plus and other products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids.
Additionally, FDA officials said, health care professionals should evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate in those who have used Reumofan Plus.
FDA ANNOUNCES RECALL OF SYNTHES HEMOSTATIC PUTTY
(AUG, 21, 2012) The Food and Drug Administration announced today that there is a Class 1 recall of Hemostatic Bone Putty because there is the potential for the medical product to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.
Hemostatic Bone Putty stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure.
The affected models and lot numbers are listed below and were manufactured between July 6, 2011 and December 14, 2011 and distributed between December 22, 2011 and June 25, 2012.
FDA officials said that on July 5, 2012, Synthes issued a Medical Device Recall letter requesting medical facilities to examine their inventory and immediately stop using the identified part and lot numbers of the Hemostatic Bone Putty.
If a facility had the affected product in stock, they were asked to call 1-800-479-6329 to obtain a Return Authorization Number, complete the verification form and return both the form and identified product to Synthes.
The FDA is encouraging health care professionals and patients to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
The affected models and lot numbers are:
Hemostatic Bone Putty
The recalling firm is: Synthes USA HQ, Inc., 1302 Wrights Lane East, West Chester, PA 19380
FDA ANNOUNCES NATIONWIDE RECALL OF DEFECTIVE GLASS VIALS WHICH COULD CAUSE SERIOUS HEALTH PROBLEMS
(AUG. 17, 2012) -- The Food and Drug Administration has announced a nationwide recall by medical products manufacturer Hospira Inc. of defective glass vials which have particles that could become dislodged and cause serious health problems to patients.
FDA officials said Hospira is recalling three lots of Propofol Injectable Emulsion, 1%, 1g/100 mL, due to visible particles embedded in the glass to the user level. Officials said there is the potential for the product to come into contact with the embedded particles and the particles may become dislodged into the solution.
FDA officials said the product is packaged in vials and indicated for the induction or maintenance of anesthesia in surgical patients or to initiate sleep in intensive care units. The affected lots were distributed nationwide to wholesalers and direct customers from September 2011 through February 2012.
Hospira officials said that if particulate matter were injected into a patient, there may be the potential for patient injuries that would require medical intervention. Risks associated with this defect could include tissue necrosis in one or more organs that could result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function, officials said.
Hospira officials said that they have not received any reports of adverse events related to these lots. Hospira said it has initiated an investigation to determine the cause of the defect and corrective and preventive measures. The investigation has preliminarily identified the root cause as a supplier glass defect. Hospira said it is working with its glass vial supplier to determine the cause of the defect.
The FDA is encouraging health care professionals and patients to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Hospira officials said the recall is being conducted as a precautionary measure. The company is notifying its distributors and customers by letters and is arranging for return/replacement etc. of all recalled products. Anyone with an existing inventory in the United States should stop use and distribution, quarantine the product immediately and call Stericycle at 1-888-410-7509, between the hours of 8 a.m. to 5 p.m. EDT, Monday through Friday, to arrange for the return of the product.
Customers can call Hospira Customer Care at 1-877-976-7747, between the hours of 8 a.m. to 5 p.m. CDT, Monday through Friday, to inquire about product availability.
Hospira described itself as the world's leading provider of injectable drugs and infusion technologies, is headquartered in Lake Forest, Ill., and has approximately 15,000 employees.
FDA ISSUES WARNING ABOUT CODEINE DANGES
TO CHILDREN THAT MAY PROVE FATAL
(AUG. 15, 2015) -- The Food and Drug Administration has issued a warning that the popular pain-killer codeine could have life-threatening effect in children who have undergone certain operations.
FDA officials said the agency is reviewing reports of children who developed serious adverse effects or died after taking codeine for pain relief after tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome. Recently, three pediatric deaths and one non-fatal but life-threatening case of respiratory depression were documented in the medical literature.
The FDA said these children (ages two to five) had evidence of an inherited (genetic) ability to convert codeine into life-threatening or fatal amounts of morphine in the body. All children had received doses of codeine that were within the typical dose range.
Children are often prescribed codeine for pain relief after surgery to remove their tonsils or adenoids to treat sleep apnea, a condition in which breathing problems make it hard for them to sleep soundly.
However, some children may be at risk of developing serious side effects, or even dying, after being given codeine in amounts that are within the recommended dose range.
The FDA said it has reviewed recent reports in medical literature of the three deaths and one life-threatening case and is warning the public that this danger exists for some children whose livers convert codeine to morphine in higher than normal amounts.
FDA wants parents and caregivers to be aware of the warning signs that could indicate their child is having trouble breathing because of this higher morphine level.
The agency is trying to determine if there have been other cases of accidental overdose or death in children taking codeine, and if there have been incidents like this when children have taken codeine after other kinds of surgical procedures, said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia and Addiction Products (DAAAP) in FDA’s Center for Drug Evaluation and Research.
Codeine is an opioid pain reliever—a narcotic medication—used to treat mild to moderate pain. It is also used to reduce coughing, usually in combination with other medications. Codeine is available by prescription either alone or in combination with acetaminophen or aspirin, and in some cough and cold medications.
Codeine is converted to morphine in the liver by an enzyme. Some people have genetic variations that make this enzyme over-active, causing codeine to be converted to morphine faster and more completely than in other people. These "ultra-rapid metabolizers" are more likely to have higher than normal amounts of morphine in their blood after taking codeine. High levels of morphine can result in breathing difficulty, which may be fatal.
From one to seven in every 100 people are "ultra-rapid metabolizers," but they are more common among some ethnic groups. Twenty-nine percent of North African and Ethiopian populations are “ultra-rapid metabolizers,” with about 6 percent of African American, Caucasian and Greek populations also affected.
The only way to know if someone is an ultra-rapid metabolizer is to do a genetic test. There are FDA-cleared tests to check for ultra-rapid metabolism.
The cases occurred in children who showed evidence of being ultra-rapid metabolizers. The children ranged in age from 2 to 5 years old. All of the children received doses of codeine that were within the typical dose range, meaning that they were not given extra amounts of the medication.
In these cases, the signs of morphine overdose developed within one to two days after the children started taking codeine.
The FDA said health care professionals should be aware of the risks of using codeine in children, particularly in those who have undergone tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome. If prescribing codeine-containing drugs, the lowest effective dose for the shortest period of time should be used on an as-needed basis (i.e., not scheduled around the clock).
Parents and caregivers who observe unusual sleepiness, confusion, or difficult or noisy breathing in their child should seek medical attention immediately, as these are signs of overdose. The FDA encouraged health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
The FDA said it is currently conducting a safety review of codeine to determine if there are additional cases of inadvertent overdose or death in children taking codeine, and if these adverse events occur during treatment of other kinds of pain, such as post-operative pain following other types of surgery or procedures.
Agency officials said they will update the public with more information once it has completed its review.
Additional Information for Parents and Caregivers:
- Codeine is usually prescribed on an "AS NEEDED" basis. Do not administer codeine to the child on a regular basis UNLESS the child requires the drug. Do not administer more than six (6) doses per day.
- Signs of serious side effects of codeine in children can include unusual sleepiness, confusion, and difficult or noisy breathing. If your child shows these signs, seek medical attention immediately by taking your child to the emergency room or calling 911.
- Talk to your child’s health care professional if you have any questions or concerns about codeine.
GIANT PHARMACEUTICAL COMPANY PFIZER AGREES TO PAY $60 MILLION IN INTERNATIONAL BRIBERY CASE
(Aug. 7, 2012) -- In a bribery scam that spanned the globe, Pfizer, one of the world's largest pharmaceutical companies, has agreed to pay $60 million to settle allegations that the company spent millions of dollars in bribes to officials in foreign countries to boost sales of its drugs and dodge government regulations. Shares of the publicly traded company immediately dropped on Wall Street.
The scope of the bribery extended from Europe to Asia and was a massive violation of the U.S. Foreign Corrupt Practices Act, said investigators from the Justice Department and Securities and Exchange Commission. According to government officials, Pfizer has agreed to pay $45 million to the SEC to settle charges that the company, along with fellow pharmaceutical firm Wyeth, which Pfizer acquired a few years ago, violated the corruption laws. The Department of Justice said that Pfizer, as part of the agreement, will pay that agency $15 million in penalties.
"Corrupt pay-offs to foreign officials in order to secure lucrative contracts creates an inherently uneven marketplace and puts honest companies at a disadvantage," said James McJunkin of the FBI's Washington field office in a statement.
The settlement is certain to add fuel the ethical debates and plaintiffs' lawsuits against Pfizer and other large pharmaceuticals companies over whether the companies put corporate profits ahead of consumer safety. There have been similar lawsuits in the United States involving allegations similar to those in this case in which drug manufacturers have been linked to paying lavish gifts, dinners and kickbacks in return for physicians prescribing their brand of medications to patients.
Consumer rights organizations such as Consumer Reports have long raised flags about benefits that physicians receive from drug manufacturers in return for serving as spokespersons for the companies and prescribing the manufacturers' drugs.
The settlement also is the latest in what government officials have described as a determined effort to stem bribery by multinational companies in foreign countries that involves several of the world's biggest pharmaceutical companies. Officials also said that there are several non-pharmaceutical corporate giants under investigation.
The allegations in the Pfizer case contain claims that Pfizer short-cut required government oversight in Bulgaria, China, Croatia, the Czech Republic, Italy, Kazakhstan, Russia and Serbia.
According to SEC officials, Pfizer officials paid large amounts of bribes to boost sales and obtain regulatory approvals.
Government officials cited examples of bribery with Chinese officials in which Pfizer employees rewarded government doctors who prescribed large amounts of the company's drugs by inviting them to meetings with "extensive recreational and entertainment activities," and in Croatia doctors received a kickback of the proceeds from Pfizer's drug sales to the doctors' own institutions.
Pfizer officials described the bribes as an aberration of which top executives were unaware. "The actions which led to this resolution were disappointing, but the openness and speed with which Pfizer voluntarily disclosed and addressed them reflects our true culture and the real value we place on integrity and meeting commitments," said Amy Schulman, executive vice president and general counsel at Pfizer, who noted that the company self reported violations that government officials said began as long ago as 2001.
Reuters News Agency reported that Pfizer in 2004 became the first pharmaceutical company to volunteer information about past wrongdoing to the Justice Department, but the case has taken years to resolve.
"Last year, Johnson & Johnson agreed to pay $70 million to settle U.S. charges that it paid bribes and kickbacks to win business in Greece, Iraq, Poland and Romania, the first such settlement by a big drug company. The 1977 Foreign Corrupt Practices Act makes it illegal for U.S. companies and foreign firms whose stock is traded in the United States to bribe government officials in foreign countries."
Eight of the world's top 10 drugmakers have warned of potential costs related to charges of corruption in overseas markets, according to a Reuters examination of U.S. filings.
Reuters reported that in the Chinese briberies, Pfizer employees hosted "club-like meetings" with recreational and entertainment activities for government doctors who wrote a lot of prescriptions.
"The company also created programs under which government doctors could accumulate points based on the number of prescriptions they wrote for Pfizer products, according to Reuters, "The points could be redeemed for gifts ranging from medical books to cell phones, tea sets, and reading glasses.
Wyeth, which Pfizer acquired in 2009, faced allegations of its subsidiaries marketing Wyeth's nutritional products in China, Indonesia and and Pakistan by bribing doctors with cash, electronic equipment and other gifts.
In agreeing to the settlements neither Pfizer and Wyeth admitted nor denied wrongdoing.
Some legal experts and consumer rights advocates said that such settlements can be small prices for large companies to pay in return for the large amount of profits that were generated by the sales of their products.
BAYER ANNOUNCES THAT NEARLY 2,000 YAZ, YASMIN LAWSUITS HAVE BEEN SETTLED; $402 MILLION PAID OUT
As thousands of Yaz and Yasmin lawsuits filed by women who claim they have suffered blood clotting and other serious health problems because of the oral contraceptives proceed in the court system the drugs' manufacturer has announced that it has paid out over $400 million to settle some of them.
In choosing to settle the cases rather to go to trial and risk larger damages the figures announced by pharmaceutical giant Bayer average out to about $212,000 in each of the cases that have been settled. The popular birth control pills have come under fire from medical researchers and consumer advocates for years over side effects that women have suffered, most prominently the danger of blood clots.
The side effects generated a landslide of lawsuits by women who said they have suffered clots, strokes, heart attacks and other health problems because of their use of the birth control pills. The links between Yaz and Yasmin and blood clots also has caused the U.S. Food and Drug Administration to order labeling warning changes.
Many of these lawsuits have been consolidated into what is called a multi-district litigation being coordinated for pre-trial evidence gathering and test trials before a federal court judge in Illinois.
The judge agreed several months ago with a request by Bayer that a special mediator – a George Washington University law professor was chosen – be appointed in an attempt to resolve some the massive load of cases.
Since then there has been an acceleration of the settlements and nearly 1,900 cases have been settled. Bayer also announced that it is setting aside over $600 million for Yaz and Yasmin settlements and Bloomberg News cited industry analysts who predicted that Bayer will eventually have to pay out over more than $2 billion Euros to resolve the cases pending.
At the center of the lawsuits are allegations that Bayer failed to properly warn consumers and government regulators about the dangers of blood clotting, which has been linked to the pills' synthetic hormone drospirenone. Bayer and other companies manufacturing drugs containing drospirenone have been directed by the Food and Drug Administration to change the warning labels on their product packaging to inform consumers about the blood-clotting danger.
The law professor selected by the judge to work as a mediator in the cases is Stephen Saltzburg, whose selection has delayed the scheduled test trials in the case while settlements continue.
The Bloomberg report quoted Saltzburg earlier this month as saying that settlement talks are continuing between the company and women's lawyers and progress is being made in resolving cases and said that he told an Illinois newspaper that "There are always some holdouts, but I think we will settle the bulk of these cases next year."
Despite the settlement costs, the Associated Press reported from Berlin that Bayer says its second-quarter earnings were a third lower than last year because of one-time charges that included money set aside to deal with the lawsuits over Yaz and Yasmin.
"Revenues rose 10 percent however and the company raised its full-year outlook," the AP reported, saying that Bayer reported net earnings of €494 million ($606 million) for April-June — down 34 percent from €747 million a year earlier. Revenues climbed to €10.18 billion from €9.25 billion.
"Earnings were weighed down by one-time deductions from earnings totaling €762 million. That included €496 million in money set aside for settlement costs from lawsuits over birth control pills marketed as Yasmin and YAZ. Bayer faces lawsuits in the United States from women claiming the contraceptive caused blood clots that led to serious health consequences.
"Otherwise the picture was brighter. Bayer said it was raising its predictions for full-year revenue and pre-tax earnings. Pharmaceutical sales rose 4.3 percent, helped by growth in the United States and China, while Western Europe declined. Sales boomed 17 percent in the company's farm chemical business, continuing strong sales from the first quarter. The company said business was helped by high prices for agricultural products."
FDA ISSUES WARNING ABOUT SEIZURE RISK WITH MULTIPLE SCLERORIS MEDICATION AMPYRA
(July 25, 2012) -- The Food and Drug Administration has issued a drug safety communication updating health care professionals and the public about the risk of seizures in patients with multiple sclerosis (MS) who are starting Ampyra (dalfampridine).
Using information received from post-market adverse event reports, FDA officials said they recently evaluated seizure risk in MS patients taking Ampyra (dalfampridine) and found that the majority of seizures occurred within days to weeks after starting the recommended dose and occurred in patients having no history of seizures.
The FDA said it is updating the Ampyra drug label to clarify recommendations.
Ampyra was approved to improve walking in patients with MS. Seizures are a known side effect of Ampyra, and seizure risk increases with higher blood levels of the drug. Ampyra is eliminated from the body through the kidneys, and patients with kidney impairment may develop higher blood levels of the drug, thereby increasing their seizure risk.
FDA officials said they are reminding health care professionals that there are age-related decreases in renal function, and mild renal impairment is common after age 50, even when serum creatinine is normal. Officials said renal function should be assessed by estimating creatinine clearance and that Ampyra should not be used in patients with a history of seizures or who have moderate to severe renal (kidney) impairment (measured as creatinine clearance [CrCl] less than or equal to 50 mL/min).
The FDA also posted this information for patients:
- Tell your health care professional if you have kidney problems.
- Your health care professional should order blood tests periodically to evaluate your kidney function.
- Do not take Ampyra if you have ever had a seizure.
- Ampyra tablets should be taken whole and not divided, crushed, chewed, or dissolved.
- Do not take double or extra doses of Ampyra if a dose is missed. Side effects, including seizures, are more frequent at higher doses.
Additional information for health care professionals includes:
- Ampyra is contraindicated in patients with a history of seizures or with moderate to severe renal impairment (CrCl < 50 mL/min).
- The potential benefits of Ampyra treatment should be carefully considered against the risk of seizures before using Ampyra in patients with mild renal impairment (CrCl 51-80 mL/min).
- A patient's CrCl (calculated using the Cockroft-Gault equation) should be known before initiating Ampyra treatment and monitored at least annually whileAmpyra treatment continues, even when serum creatinine levels appear to be normal.
- Tell patients they should not take double or extra doses of Ampyra if a dose is missed. Adverse effects, including seizures, are more frequent at higher doses.
- Ampyra should be discontinued permanently if a seizure occurs.
The FDA is asking health care professionals and patients to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
INTERNATIONAL ORGANIZATION CALLS FOR BAN ON ASBESTOS BECAUSE OF HEALTH HAZARDS
(July 24, 2012) -- One of the most sweeping indictments of asbestos was issued today by a respected international consortium of health experts that studies the causes and prevention of disease epidemics.
The Joint Policy Committee of the Societies of Epidemiology (JPC-SE) announced that it is calling, for the first time, for a global ban on the mining, use, and export of all forms of asbestos. The statement has already been endorsed by over 150 public health, civil society organizations and individual scientists from twenty countries.
Asbestos has long been identified as a toxic material that causes a variety of fatal illnesses, most commonly malignant mesothelioma, an aggressive cancer caused by exposure to asbestos. Most victims develop the disease after inhaling microscopic asbestos fibers which work their way into the linings of the lungs, heart or abdominal organs and generate cancer cells.
The JPC-SE is a consortium of 13 epidemiology societies, national and international in scope, organized to coordinate and unify joint policy actions among societies of epidemiologists, globally. Membership of the JPC-SE is open to all participating societies, each with one vote; each society appoints its own representative(s).
The JPC-SE meets on a regular basis, primarily via teleconference. It serves as a forum in which concerns of a policy nature about any aspect of epidemiologic research and practice can be discussed. This includes such items as certification, core competencies, funding of epidemiologic research, governmental policies affecting epidemiologic research, ethics guidelines. It provides an international forum for brainstorming issues that cross political boundaries. It is a network in which all epidemiology societies can be engaged to discuss issues relating to both research and practice in the public interest.
The statement was issued to the media from Ottawa, Canada, in the midst of a national debate in that country over plans to re-start the former Johns-Manville mine in Quebec and export millions of tons of asbestos overseas over the next 20 years. Approval by the government to guarantee loans to the project have generated headlines and controversy over economical, ethical and health issues centered on the dangers of asbestos.
The consortium said that "Despite grave warnings, put forward by a variety of cancer, public health, and regulatory agencies, regarding the health hazards of all types of asbestos, controversy continues to be fomented by powerful moneyed interests. This has permitted some countries to promote continued use of asbestos. The JPC-SE therefore undertook the development of a Position Statement that, for the first time, puts forward, from an epidemiologic perspective, the clear evidence confirming that all forms of asbestos should be banned."
The consortium, in its statement said a rigorous review of the epidemiologic evidence confirms that all types of asbestos fibers are causally implicated in the development of various diseases and premature death. Numerous well-respected international and national scientific organizations, through an impartial and rigorous process of deliberation and evaluation, have concluded that all forms of asbestos are capable of inducing mesothelioma, lung cancer, asbestosis and other diseases.
"These conclusions are based on the full body of evidence, including the epidemiology, toxicology, industrial hygiene, biology, pathology, and other related literature published to the time of the respective evaluations, according to the statement.
The consortium also pointed out that industrialized countries have virtually ceased using asbestos and over 50 countries have passed laws banning its use. Consequently, the asbestos industry, to establish new markets, is promoting the use of asbestos in low-to-middle income countries, particularly in Asia, and has created lobby organizations to achieve this goal.
"In spite of the scientific evidence and calls to end all use of asbestos by many organizations including the World Health Organization, the World Federation of Public Health Associations, the International Commission on Occupational Health, the International Social Security Association, the International Trade Union Confederation and the World Bank, the use of asbestos is increasing in low-to-middle income countries," according to the statement.
"There is little awareness in these countries of the risk that asbestos poses to health; in addition, safety regulations are weak to non-existent. If unstopped, this continued and increasing use of asbestos will lead to a public health disaster of asbestos-related illness and premature death for decades to come in those countries, repeating the epidemic we are witnessing today in industrialised countries that used asbestos in the past."
The JPC-SE statement:
- 1-- Calls for a global ban on the mining, use, and export of all forms of asbestos;
- 2 -- Calls specifically on the major asbestos exporting countries – Brazil, Canada, Kazakhstan, and Russia – to respect the right to health by ceasing the mining, use, and export of asbestos, and providing transition assistance to their asbestos-mining communities;
- 3 -- Calls specifically on the major asbestos-using countries – Brazil, China, India, Indonesia, Iran, Kazakhstan, Russia, Sri Lanka, Thailand, Ukraine, Uzbekistan, and Vietnam – to cease use of asbestos;
- 4 -- Urges sister societies of epidemiology and/or public health organizations and agencies, particularly in those countries that continue to mine, use and/or export asbestos, such as Brazil, Canada, China, India, Indonesia, Iran, Kazakhstan, Russia, Sri Lanka, Thailand, Ukraine, Uzbekistan, and Vietnam, to adopt a position calling for a ban on the mining, use, and export of all forms of asbestos;
- 5 -- Urges all countries that have used asbestos to inform their citizens and their healthcare professionals of the hazards of asbestos and to implement safety measures to monitor the health of exposed citizens. To facilitate this, an inventory of asbestos already in place is needed, particularly in schools and places where children are present; and
- 6 --Urges all sister societies of epidemiology and/or public health organizations and agencies to support the right of scientists and academics to carry out their work free from intimidation. In situations where the asbestos industry files legal cases to silence scientists and academics, societies of epidemiology and/or public health organizations and agencies are urged to examine the situation and, if warranted by the facts, to support the scientists or academics being threatened and to denounce such tactics of intimidation. The procedure developed by the International Society for Environmental Epidemiology for dealing with beleaguered colleagues could be followed as a model.
The JPC-SE said it has strived to address policy issues that relate to the practice of epidemiologic research, find appropriate venues for the translation of current epidemiologic findings into policy, promote the professional interests of the discipline of epidemiology in governmental organizations, and identify the strategies and processes for shared decision-making among JPC-SE members to develop rational, effective and cost-conscious policies.
JUDGE COMES DOWN HARD ON CONSTRUCTION COMPANY IN NEW JERSEY LANDFILL ASBESTOS CASE
Judges and prosecutors have been stepping up their enforcement of asbestos laws recently in numerous cases across the country in which contractors and other businesses handling or removing asbestos have failed to meet safety standards.
There is a significant health hazard involved because exposure to asbestos is the overwhelming cause of an aggressive, incurable cancer known as malignant mesothelioma. The cancer develops after victims unknowingly inhale microscopic asbestos fibers, usually in a job-related setting. National health statistics show that there are about 2,000 to 3,000 new cases of malignant mesothelioma diagnosed in the United States each year.
The most recent asbestos case involves a company in New Jersey, Strategic Environmental Partners, that is embroiled in a controversy with the Department of Environmental Protection in regard to the Fenimore landfill on Mooney Mountain near Morristown.
The company is attempting to fill in the landfill and cap it in order to construct a solar panel farm. The company president, Richard Bernardi, obtained the required permits from the Department of Environmental Protection but that agency is now seeking to revoke those permits over violations agency officials claim have been committed in the project.
One of the problems is the discovery of asbestos at the site, which contains a large amount of construction debris, a frequent source of asbestos because the material was used for many decades in the insulation of buildings.
Now, reports the Roxbury Register newspaper, Superior Court Judge Deanne Wilson, has ordered that Bernardi immediately present her with a plan for how his company will deal with the problem and comply with environmental safety laws.
At stake, apparently, is the project, which cannot be completed unless Bernardi finds a way to protect his workers and the public from the dangers of asbestos exposure.
"Following a random inspection on July 3 by the DEP and state Department of Labor, some asbestos was detected at the landfill," DEP spokesman Robert Considine told the newspaper. "Seven samples were taken at the site and three of them were positive from asbestos."
Considine also told the newspaper that the agency is attempting to have the permits revoked because Bernardi's company has committed many violations of environmental laws: "Bernardi is, and has been in violation of the consent order and closure plan that was approved by the DEP. It is the DEP's position that we are seeking an immediate stop to the daily truck deliveries due to these asbestos violations."
The newspaper also reported that while this legal dispute has been going on dozens of dump trucks have been driving to and from the site over the last several months over residential roadways. "In June, one of the dump trucks took a non-approved route to the site, and wound up flipping over in the roadway. It took Roxbury crews hours to clean up the mess," according to the report.
Strict environmental laws involving asbestos have been in place since the 1970s, when the government acknowledged the deadly nature of asbestos exposure and enacted strict laws on the use, handling and disposal of asbestos.
Since then, there have been numerous civil and criminal prosecutions of offenders, including many business officials, contractors and some inspectors with stiff fines and some prison sentences handed down to offenders.
Most victims of malignant mesothelioma are told they will have less than 18 months to live after being diagnosed. This is due, in part, to the fact that there is a long latency period between the time the toxic fibers are inhaled and lodge in the linings of the lungs, heart or abdominal organs and the time that cancer cells are generated.
Most victims are not diagnosed until they are in their late 50s, 60s or 70s and the cancer is usually so far advanced it is untreatable by traditional medical approaches of surgery, chemotherapy or radiation.
INTRA-AORTIC BALLON PUMPS RECALLED OVER POSSIBLE LIFE-THREATENING DANGERS
The Food and Drug Administration has announced that Datascope Corp/Maquet has initiated a Class 1 voluntary worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) over possible life-threatening problems.
Company officials said the IABPs were manufactured with an affected power supply, or may have received an affected power supply during an upgrade/service of the IABP in the field and that in specific units, the fan assembly of the power supply could potentially contain a misshapen retaining ring.
Officials said this retaining ring could disengage within the fan, causing the fan blade assembly to stop rotating. Consequently, the power supply would detect an overheating event, and shut down without visual or audible alarms. The data to date indicates that there is a very small likelihood for an IABP to contain a misshapen retaining ring. This device failure may result in unanticipated interruption of counterpulsation therapy, according to company officials.
The FDA has classified this action as a Class 1 recall. FDA defines Class I recalls as, "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
The affected units were sold under the Datascope Corp. System 98/98XT (Part numbers: 0998-00-0446-xx, 0998-UC-0446-xx, 0998-00-0479-xx, 0998-UC-0479-xx), CS100/CS100i (Part Numbers: 0998-00-3013-xx, 0998-UC-3013-xx, 0998-UC-0446Hxx and 0998-UC-0479Hxx) and CS300 ( Part Numbers: 0998-00-3023-xx, 0998-UC-3023-xx) IABP brand names.
Customers who have 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABPs) sold under the Datascope Corp. System 98/98XT, CS100/CS100i and CS300 IABP brand names which are being recalled may schedule a visit by a company service representative.
Company officials said a total of 840 US customer IABPs and 453 international customer IABPs are affected by this field correction. Between May 2008 and Datascope Corp/Maquet officials initiated the field correction in March 2011 and at that time notified all customers that may have an IABP affected by this field correction. They said the corrective action associated with this field correction is to provide an upgraded power supply to all IABPs containing an affected power supply and that a service representative will conduct the upgrade and document this corrective action during a visit to the customer. To date, 55% of US customer units have been completed and every effort is being made to complete all affected domestic IABPs as soon as possible, company officials said.
The FDA said that any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program at the agency web site.
DRUGMAKER HIT WITH $3 BILLION FINE FOR FRAUDULENT ACTIVITIES INVOLVING PAXIL, AVANDIA AND WELLBUTRIN
July 2, 2012 -- GlaxoSmithKline, one of the world’s pharmaceutical giants, has been hit with a $3 billion fine by the government for fraudulent actions in its marketing and sales of some of its most popular and best-selling medications.
The U.S. Justice Department announced the fine and said that the company has agreed to pay $1 billion in criminal fines and $2 billion to fund civil liabilities in what officials described as the biggest such settlement in history. The charges involve such familiar drugs as Avandia, Paxil and Wellbutrin.
In addition to the government charges, GlaxoSmithKline is facing thousands of Avandia and Paxil lawsuits filed by patients who claim they are the victims of serious side effects from their use of the medications. The government said the company withheld from the public and health care professionals important safety data about the dangers of these drugs.
According to a CNN report about the agreement with the Justice Department:
- GlaxoSmithKline will plead guilty to two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce. Specifically, the government alleged that the drugs were marketed as a treatment for conditions for which they had not been approved. It said Paxil, which treats depressive and anxiety disorders in adults, was marketed to children and adolescents, and Wellbutrin, an antidepressant, was marketed as a weight-loss aid.
- A third count involves a failure to report safety data about the drug Avandia, a diabetes drug, to the Food and Drug Administration between 2001and 2007.
- In addition to the criminal and civil resolutions, GlaxoSmithKline has reached a 5-year compliance agreement with the Department of Health and Human Services. Under terms of the deal, according to department Inspector General Daniel R. Levinson, company executives could forfeit annual bonuses if they or their subordinates engage in significant misconduct, and sales agents are now being paid based on quality of service rather than sales targets.
In at least one major medical research study cited by the FDA women who used Paxil to combat depression and other mental ailments during their pregnancies were more than twice as likely to give birth to infants with birth defects as women who did not use Paxil.
Paxil was first introduced to the market in 1992 and quickly became one of the leading anti-depressants prescribed and sold in the United States and other parts of the world. There were no descriptions of severe side effects issued by the drug’s manufacturer and no mention about the possibility of women giving birth to children with birth defects if they used Paxil during their pregnancy.
In the years that followed Paxil’s debut some women began coming forth with claims that Paxil might have affected their infants’ health. Those claims were quickly dismissed by Paxil’s manufacturer, GlaxoSmithKline. The company also vigorously disputed follow-up medical research by respected medical sources that concluded that women who use Paxil during a pregnancy were at a much higher risk of giving birth to children with defects.
In the case of Avandia, there are numerous Avandia lawsuits working their way through the court system involving allegations that patients suffered heart attacks that they attribute to their use of the drug.
LATEST MEDICAL RESEARCH STUDIES RAISES MORE SAFETY CONCERNS ABOUT STATIN DRUGS
Recently announced findings from medical researchers are raising new concerns about the side effects of statins, the newer class of anti-cholesterol drugs that have become one of the most prescribed medications in the United States and elsewhere. These drugs –which are used by patients suffering from high cholesterol in an attempt to ward off heart disease – already have been linked to greater risk of developing diabetes or cardiac problems.
Now come findings from a study conducted by researchers at the University of California at San Diego which showed that among patients participating in the project the drugs were linked to fatigue, a loss of energy and tiring faster while exercising. Statins are designed to lower blood cholesterol by blocking the workings of a chemical in the liver that is involved in the production of cholesterol, which plays a positive role in body processes unless it increases to a level in which it can cause atherosclerosis, a disease in which plaques develop and clog arteries, blocking the normal flow of the bloodstream. Among the most popular statins are Lipitor, Pravachol , Crestor, Zocor, Lescol and Vytorin..
Statins, while a huge commercial success for pharmaceutical firms and a positive medication for many millions of people suffering from cholesterol problems, has, for some patients had devastating effects.
The national, non-profit consumer organization Public Citizen, for example, has raised questions about the safety of statins and put Crestor (rosuvastatin) on the organization's DO NOT USE drug list "because it causes kidney muscle and liver damage." Several independent medical research studies have reached similar conclusions.
Several months ago the Food and Drug Administration announced that the warning labels of some statins were being changed to reflect concerns raised about the possibility of patients being put at increased risk of developing diabetes and forgetfulness.
"The medical community needs to spend more time asking whether the benefits of these drugs outweigh the risks for certain patients," said Beatrice Golomb, the study's author and a professor of medicine at the UCSD School of Medicine, in an interview with U-T San Diego about the study.
The U-T report said that UCSD's study involved more than 1,000 generally healthy adults from San Diego and participants were given statins or placebos.
"Those placed on statins were significantly more likely than those on placebo to report worsening in energy, fatigue-with-exertion, or both," the paper quoted Golomb as saying in summarizing the findings."Both statins contributed to the finding, though the effect appeared to be stronger in those on simvastatin (a drug that led to greater cholesterol reduction.)"
"Side effects of statins generally rise with increasing dose, and these does were modest by current standards." Golomb said. "Yet occurrence of this problem was not rare, even at these doses, and particularly in women."
The newspaper's report also pointed out the debate over the safety of the drugs and quoted Eric Topol, chief academic officer of Scripps Health, who the paper said pointedly disagreed earlier this year when the FDA said that statin users faced only a "small" risk of developing diabetes and forgetfulness.
"The risk is at least 1 of every 200 people taking a statin which could be as many as 100,000 diabetics in the US that are statin-induced," Topol said.
Public Citizen was particularly outspoken about the dangers of statins such as Crestor. It has petitioned the FDA to ban the drug in very strong language:
"Clearly, the only 'appropriate' and safe risk-management strategy for rosuvastatin (Crestor) would have been not to have approved the drug in the first place. In summary, rosuvastatin has no proven health benefit in people with elevated cholesterol levels. As discussed above, it has caused potentially serious kidney toxicity that is not seen with the other statins; it is the only statin that caused rhabdomyolysis, a life-threatening adverse drug reaction, in preapproval clinical trials; and there are already four statins on the market that safer than rosuvastatin and have demonstrated a health benefit to patients."
HYDROCHLORIDE INJECTION RECALLED OVER FEARS OF LIFE-THREATENING EFFECTS
May 14, 2012 - The U.S. Food and Drug Administration has announced that Hospira, Inc. has notified health care professionals of a recall of a lot of hydromorphone hydrochloride injection 1 mg/ml over due to reports of a single Carpuject containing more than the 1 ml labeled fill volume.
FDA officials said opioid pain medications such as hydromorphone have life-threatening consequences if overdosed, including respiratory depression (slowed breathing or suspension of breathing), low blood pressure, and reduced heart rate including circulatory collapse.
The FDA said the affected lot number is 07547LL, with an expiration date of July 1, 2013. The affected lot was distributed between September and October, 2011. It was initially distributed to wholesalers and a limited number of hospitals in Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Indiana, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington, and Wisconsin.
BAYER YASMIN LAWSUIT SETTLEMENTS AND CLAIMS CONTINUE TO CLIMB, NOW UP TO $142 MILLION
APRIL 26, 2012 - Bayer has now paid victims of blood clots and other side effects to $142 million, which is about $218,000 per case.
A recent statement from the company mentions "Bayer is only settling claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism) after a case specific analysis of medical records." So far Bayer has faced 11,900 lawsuits over Yaz and Yasmin from about 14,000 plaintiffs.
Read more about the Yasmin Blood Clot lawsuit
FDA ANNOUNCES BACTERIA CONTAMINATION IN GEL
The U.S. Food and Drug Administration has announced that bacteria has been found in Other-Sonic's Generic Ultrasound Transmission Gel. The agency is informing consumers, risk managers OB/GYNs and radiologists that health care professionals and facilities should immediately stop using any such product manufactured between June and December of 2011.
FDA officials said the bacteria Pseudomonas aeruginosa and Klebsiella oxytoca were found to have contaminated lot numbers 060111, 090111, and 120111. These lots are sold in 250 milliliter (ml) bottles and 5 liter (l) dispensing containers.
The FDA said Pseudomonas aeruginosa is found most often in water and soil. Patients exposed to the bacteria on the surface of their skin could develop inflammatory dermatitis, even on intact skin. Klebsiella bacteria is often found in the digestive tract where they do not often cause infection; however, when the lungs or other tissues are exposed to Klebsiella bacteria, either minor problems or more serious infections, such as pneumonia, wound infection, or bloodstream infections, could occur.
The FDA said Other‐Sonic Generic Ultrasound Transmission Gel, manufactured by Pharmaceutical Innovations Inc. is a non‐sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
The FDA is recommending that these lots not be used and that patients who have been exposed to these lots of Other‐Sonic Generic Ultrasound Transmission Gel should be identified. Those involved in the use of the gel should review the procedures they underwent and the outcomes of those procedures and determine if further evaluation is needed, the FDA said.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. The warning was issued April 18, 2012 from the FDA headquarters in Silver Spring, Md.
FDA CONFIRMS BLOOD CLOT DANGERS IN CONTRACEPTIVES SUCH AS YAZ, YASMIN CONTAINING DROSPIRENONE
APRIL 10, 2012 – The U.S. Food and Drug Administration announced today that its review of birth control pills such as the top-selling Yaz and Yasmin that contain drospirenone has confirmed that the medications put women at higher risk of suffering blood clots.
FDA officials said that they are adding new labeling requirements to warn women that these newer class of oral contraceptives put women at higher risk of suffering life-threatening blood clots than older types of oral birth control pills.
"The FDA has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills," the agency said in a press release announcing the findings of a closely watched review. "Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills."
Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin. The FDA said it is adding information about the studies to the labels of drospirenone-containing birth control pills.
Agency officials said the revised drug labels will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products. The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.
The FDA is recommending that women meet with their health care professional about their risk for blood clots before deciding which birth control method to use. The agency said health care professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman's risk for developing a blood clot before prescribing these drugs.
The FDA also encouraged health care professionals and patients to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program on the FDA web site.
The FDA said the studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not. The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots, officials said. The FDA said it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills.
FDA officials said the revised drug labels will appear on such contraceptives as Yaz, Yasmin, Safyral and Beyaz to report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins.
"To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period," the FDA said in its press release.
"Figure 1 shows the risk of developing a blood clot for women who are not pregnant and do not use birth control pills; for women who use birth control pills; for pregnant women; and for women in the postpartum period. For example: If 10,000 women who are not pregnant and do not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot."
Figure 1: Likelihood of Developing a Blood Clot
Click here for graph
COC = combination oral contraceptives or birth control pills
The FDA said these studies were discussed at the joint meeting of the agency's Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011.
The FDA had issued previous Drug Safety Communications related to the risk of blood clots with birth control pills that contain drospirenone in 2011.
Agency officials said that they will communicate any new information on drospirenone-containing birth control pills and the risk of blood clots when it becomes available. Click here for a list of the drospirenone-containing contraceptives.
March 21, 2012: NEW ALLEGATIONS SURFACE ABOUT UNAPPROVED SALES OF JOHNSON & JOHNSON TRANSVAGINAL MESH PRODUCTS
Giant pharmaceutical Johnson & Johnson - already facing hundreds of transvaginal mesh lawsuits - is now being confronted with additional allegations that it sold a model of the mesh for three years before it received the required approval of the Food and Drug Administration.
Legal experts say this news will make it even more difficult for Johnson & Johnson to defend itself against the lawsuits filed against it across the country by transvaginal mesh victims because it damages the company's credibility in terms of its claims that it puts consumer safety ahead of corporate profits.
Johnson & Johnson is one of several transvaginal mesh manufacturers who have been named in transvaginal mesh lawsuits filed by women who have developed serious health issues as a result of implants they received to treat incontinence and a condition known as pelvic organ prolapse (POP). The conditions are not infrequent in women as they age and their abdominal muscles weaken, causing internal organs to drop.
Among the health problems named in the lawsuits are mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems. Among the other major firms that have been sued are American Medical Systems, Bard and Boston Scientific. Several legal experts say another factor that works against Johnson & Johnson is that four subsidiaries have pleaded guilty to either bribery or illegal marketing charges over the last few years Read more about the Transvaginal Mesh Lawsuits
Bayer Healthcare Reaches a Settlement in 70 Yaz Side Effects Lawsuits
News reports are filling the online world with information that Bayer Healthcare has agreed to settle approximately 70 lawsuits filed on behalf of women who were injured by Yaz birth control pills. The total amount of the settlements is not known at this time. The FDA approved Bayer Healthcare's birth control product back in 2006. This drug contains drospirenone, which is a chemically synthetic form of progrestin that is used in newer forms of oral contraceptives. It's believed that drospirenone use may be linked to a number of serious complications including blood clots, deep vein thrombosis, pulmonary embolism and stroke.
In 2011 the FDA reported that women who have taken Yaz had a 75% chance of developing a blood clot. 2 months later an FDA advisory panel meet to discuss recent medical reports that were beginning to surface. The FDA concluded that a stronger warning be placed on the products box labels. The legal community reacted as well with reportedly thousands of women filing Yaz lawsuits thought the country. Because of the massive amount of these lawsuits, they have been consolidated into a multidistrict litigation in the U.S. District Court for the Southern District of Illinois. If you or someone you know has suffered any side effect from taking Yaz birth control please visit this page Yaz lawyer.
FDA ANNOUNCES RECALL OF DEFIBRILLATORS
The Food and Drug Administration is notifying health care professionals and patients about a Class 1 recall of automated external defibrillators (AEDs) that have a defective component that may fail unexpectedly and put patients at risk of death.
FDA officials said that if the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy, causing serious adverse health consequences, including death. The unit’s self test may not detect the failure or impending failure of the component, agency officials said. These products are used for emergency treatment of victims showing symptoms of sudden cardiac arrest who are unresponsive and not breathing. These AEDs were manufactured and distributed from July 1, 2011 through December 30, 2011.
The FDA is recommending that affected customers contact the recalling firm, Cardiac Science Corporation, of Bothell, Wash., to arrange for delivery of shipping materials for an immediate return of their AEDs for repair. The affected devices will receive a hardware correction, and the same serial number device will be returned to the customer in most cases.
The affected units are the Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators. The affected models include:
• Powerheart 9300A, 9300E, 9300P, 9390A, and 9390E
• CardioVive 92532, 92533
• CardioLife 9200G and 9231
• GE Responder and Responder Pro
• Nihon-Kohden AEDs
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
FDA officials also asked health care professionals and consumers to report adverse reactions or quality problems they experienced using these products to the FDA MedWatch program on the agency web site. The recall was announced March 2 from the FDA headquarters in Silver Spring, Md.
FDA ANNOUNCES RECALL OF FLIGHT MEDICAL CABLE FOR VENTILATOR
The Food and Drug Administration has announced that a Class 1 recall has been issued for the Flight Medical V24-00400-29 cable because the cable may cause an electrical shortage that can cause Newport HT50 ventilators manufactured prior to 2007 to shutdown unexpectedly.
The FDA said the V24-00400-20 cable is an accessory intended to transfer the alarm signal from a Newport HT50 ventilator to a nurse station. The affected cables were distributed between April 25, 2007 and July 6, 2011.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
FDA officials said that on August 23, 2011, Flight Medical sent an urgent recall notice to affected customers through its distributor, Newport Medical. Affected customers were advised to take the following actions:
- Stop using the alarm cable immediately
- Contact Newport Medical in order to receive an upgraded version of the cable free of charge.
- Address inquiries related to this action to Newport Medical's Technical Service Group at 1-800-451-3111, extension 500.
- Dispose of affected cables according to local municipal guidelines.
The FDA also encouraged health care professionals and patients to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program at the FDA web site.
This announcement was issued by the FDA Feb. 28, 2012 from the agency headquarters in Silver Spring, Md.
FDA ANNOUNCES NEW WARNINGS ABOUT CRESTOR, OTHER STATINS USED TO TREAT HIGH CHOLESTEROL
The U.S. Food and Drug Administration is announcing important new safety label changes for the class of cholesterol-lowering drugs known as statins. The agency said these changes were made to provide the public with more information for the safe and effective use of statins and are based on FDA's comprehensive review of the statin class of drugs. Statins are one of the most prescribed and commercially successful classes of drugs in the world pharmacy.
Statins are a class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol ("bad cholesterol"). Marketed as single-ingredient products, including Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Also marketed as combination products, including Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).
While statins have been an incredible success story in reducing cholesterol in many patients there have been serious side effects reported from research studies and allegations raised in Crestor lawsuits about dangerous results from the use of the medication. Among the concerns raised are rhabdomyolysis, kidney toxicity and liver problems as well as heart attacks and diabetes.
ADDITIONAL INFORMATION FOR PATIENTS
The statin drug labels have been revised to provide patients with more information on the safe and effective use of statins. Patients should be aware of the following information:
- There have been rare reports of serious liver problems in patients taking statins. Patients should notify their healthcare professional right away if they have the following symptoms: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-colored urine; or yellowing of the skin or the whites of the eyes.
- Memory loss and confusion have been reported with statin use. These reported events were generally not serious and went away once the drug was no longer being taken.
- Increases in blood sugar levels have been reported with statin use.
- Certain medicines should never be taken (are contraindicated) with lovastatin (Mevacor) (see Lovastatin Dose Limitations below).
- Patients should contact their health care professional if they have any questions or concerns about statins.
Patients should report side effects from the use of statins to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of the page.
FDA ANNOUNCES RECALL OF NEMSCHOFF PEDIATRIC BASSINETS
The Food and Drug Administration has announced a Class 1 recall of some models of Nemschoff Chairs, Inc.'s Perinatal Pediatric Hospital Beds. The company has issued the recall of these pediatric hospital bed (bassinet) products in order to correct issues with the wheels (casters), door hinges and drawer slides on the cart's frame.
Company officials said the doors and drawers may inadvertently open while the bassinet is in motion and the product may be difficult to maneuver due to its swivel caster configuration. If either of these events were to occur, there is the potential for injury to the patient, including death and other serious health consequences.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The FDA said the bassinet is intended for medical purposes for the individual care of infants. The bassinet consists of an infant tray with mattress which sits on top of a wheeled cart and may include a tub for bathing. The cart's frame can include drawers, shelving or cabinetry and the wheels (casters) located under the cart allow for infant transportation throughout the health care facility.
The affected products are Models BSNT/01 and BSNT/02, which were manufactured between November of 2003 and February of 2008, and Models BSNT/03 and BSNT/04, which were manufactured from November of 2003 to present.
Nemschoff Chairs, Inc. also has added labeling to the products regarding drawer weight limits, and specific instructions for cleaning the bassinet tub. This product may cause serious adverse health consequences, including death.
FDA officials said Nemschoff sent an "Important Medical Correction" letter and email on October, 14, 2011 to its customers. The letter described the product, problem, and action to be taken. The customers were instructed to check their inventory, isolate and hold product until they receive instructions for servicing the units.
Customers were also instructed to document all corrections on the correction acknowledgement Letter once corrections are complete on the units at their locations, and return to the letter to Nemschoff, Inc.
The FDA encouraged health care professionals and consumers to report adverse reactions or quality problems they experienced using these products to the FDA's MedWatch program on the agency web site.
TYLENOL INFANTS MEDICATION RECALLED
More than half a million bottles of the popular Infants Tylenol are being recalled because the manufacturers have received an increasing number of complaints about problems that parents are having with the medications dosing system.
The announcement was made by pharmaceutical firm McNeil, a unit of Johnson & Johnson, and involves about 574,000 bottles of Infants' TYLENOL Oral Suspension, 1 oz. Grape, which was distributed nationwide in the United States. Infants' TYLENOL is an over-the-counter (OTC) product that is frequently used for children as a pain reliever/fever reducer.
McNeil officials said they were initiating this voluntary recall as a precaution after receiving "a small number of complaints" from consumers who reported difficulty using the Infants TYLENOL SimpleMeasure dosing system. SimpleMeasure includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or "flow restrictor," at the top of the bottle to measure the proper dose.
In some cases, McNeil officials said, the flow restrictor was pushed into the bottle when inserting the syringe. Children's TYLENOL products are intended for children two years of age and older and remain available.
Company officials said that no adverse events associated with this action have been reported to date and described the risk of a serious adverse medical event as "remote." They said consumers can continue to use Infants TYLENOL provided the flow restrictor at the top of the bottle remains in place. The company discussed how to use the product's dosing system in a separate message to consumers also issued today.
If the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product. Consumers can request a refund by visiting the Tylenol web site or contacting McNeil. Parents and caregivers with any health questions or concerns should contact their healthcare provider and visit www.tylenol.com for additional information.
FDA ANNOUNCES RECALL OF SALTER LABS BUBBLE HUMIDIFIER BECAUSE OF POSSIBLE DEATHS
The Food and Drug Administration has announced a Class I recall of the Salter Labs 7600 Bubble Humidifier. FDA officials said the recall was issued after a manufacturing defect was discovered in certain lots of the 7600 Bubble Humidifiers, where the humidifier lids failed to pop off at the intended pressure.
Officials said that when the pop-off occurs, the brass slug does not always reseat to the appropriate position. When the slug fails to reseat properly, the humidifier can leak and a humidifier leak will potentially interrupt the flow of supplemental oxygen to the patient. Hypoxemia may develop resulting in death or serious adverse health consequences.
The FDA said that company officials said that for conscious adult patients and in hospital settings with well-trained personnel, the leak characteristic of this defect would be obvious. However, for an unconscious, critically ill patient, or for an infant, or child patient, or a home care patient, the leaking may not be obvious to the patient or to the caregiver in a home care situation. A humidifier leak will potentially interrupt the flow of supplemental oxygen to the patient. Hypoxemia may develop resulting in death or serious adverse health consequences. The firm said that it has currently not received any reports of fatal incidents.
FDA ANNOUNCES CLASS 1 RECALL OF SILICONE DEFIBRILLATION LEADS
The Food and Drug Administration has announced that a Class 1 recall has been placed upon St. Jude Medical Inc. silicone defibrillation leads because of the potential risk of serious injury or patient death if the affected devices malfunction.
FDA officials cited a press release issued by the global medical device company informing the public that a voluntary medical device advisory letter it had sent to physicians on Nov. 28 regarding the performance of Riata and Riata ST Silicone Defibrillation Leads, is now a Class I Recall.
St. Jude officials said an estimated 79,000 Riata and Riata ST family of silicone leads remain active in patients in the United States. The company said it stopped distributing the Riata and Riata ST family of silicone leads in December 2010. The affected model numbers are the Riata (8F) Silicone Endocardial Defibrillation Leads (Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, and 1592), and the Riata ST (7Fr) Silicone Endocardial Defibrillation Leads (Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, and 7042).
The FDA said it has classified this recall as a Class I recall because of the potential risk of serious injury or patient death if affected devices malfunction. St. Jude officials said the clinical implications of externalized conductors in a defibrillation lead without electrical anomalies are not fully known or understood at this time. Externalized conductors can present as only a visual observation on x-ray or fluoroscopy without any associated clinical or device-related observation, they said.
St. Jude officials said that if the electrical integrity of a lead were to be compromised, failure to deliver appropriate therapy, or the delivery of inappropriate therapy, could potentially occur, and could lead to a serious adverse event or death. Reports to St. Jude Medical associated with extraction of a Riata lead with externalized conductors include two patient deaths and one serious injury (effusion requiring thoracotomy), St. Jude officials said. In addition, one patient death and one serious injury in patients with externalized conductors were reported, but were determined not to be due to the presence of externalized conductors, company officials reported.
St. Jude Medical requested that all leads with an externalized conductor, with or without an associated electrical abnormality, be reported to the company's Technical Services Department at 1-800-722-3774. The company said it strongly encourages that any experience with screening of Riata leads for externalized conductors be shared with the company, including information regarding a lead or leads in which externalized conductors are not present. If a lead has been removed from the patient, St. Jude Medical requests that it be returned to the company, at company expense, for failure analysis to further understand this particular failure mechanism.