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.
SMUCKER'S PEANUT BUTTER RECALLED
The Food and Drug Administration has announced that the J.M. Smucker Company today began a limited voluntary recall on two specific Best-If-Used-By dates of 16 oz. Smucker's Natural Peanut Butter Chunky because it may be contaminated with salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
The FDA said healthy persons infected with salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
The FDA said the affected products were distributed to outlets in: Arkansas, Colorado, Delaware, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, South Dakota, Texas, Virginia, Wisconsin, and the District of Columbia.
Agency officials said the recall was initiated as the result of a routine sampling program by the company, which revealed that these finished products may contain the bacteria. Consumers who have purchased Smucker's Natural Peanut Butter Chunky with the above Production Code and Best-If-Used-By dates are urged to discard the product immediately and call the company at 1-888-550-9555 for a replacement coupon.
- UPC: 5150001701 (located on the side of the jar's label below the bar code)
- Production Codes: 1307004 and 1308004
- Best-If-Used-By dates: August 3, 2012 and August 4, 2012
- Chunky product only (not creamy)
- Impacted product would have been purchased between November 8 - 17, 2011
FDA ANNOUNCES RECALL OF ENVE VENTILATORS
The Food and Drug Administration has announced a Class I recall of all EnVe Ventilators, model 19250-001, manufactured between December 2010 and May 2011, due to potential defects that can interrupt ventilation to the patient. The issues include: a potential delay in resuming ventilation after reconnection; a potential automatic reset; and a potential for disconnection during transport. Agency officials said that failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death.
The CareFusion EnVe Ventilator is a portable ventilator used to provide breathing assistance to pediatric and adult patients in hospital and medical transport settings. The FDA said CareFusion officials are contacting facilities to coordinate hardware and software updates for affected ventilators.
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.
FDA STILL CONCERNED ABOUT BLOOD-CLOTTING RISKS WITH YAZ, YASMIN AND OTHER DROSPIRENONE MEDICATIONS
The U.S. Food and Drug Administration has announced that it is informing the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills such as Yaz and Yasmin.
FDA officials said the agency has completed its review of the two 2011 studies that evaluated the risk of blood clots for women who use drospirenone-containing birth control pills, previously mentioned in FDA's Drug Safety Communication issued on May 31, 2011. The FDA said it is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.
Given the conflicting nature of the findings from six published studies evaluating this risk, as well as the preliminary data from the FDA-funded study, the FDA said it has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011 to discuss the risks and benefits.
The agency recommended that patients should talk to their health care professional about their risk for blood clots before deciding which birth control pill to use. Known risk factors that increase the risk of a blood clot include smoking, being overweight (obesity), and family history of blood clots, in addition to other factors that contraindicate use of birth control pills.
The agency said women currently taking a drospirenone-containing birth control pill should be informed of the potential risk for blood clots. FDA previously communicated preliminary information about these concerns to the public on May 31, 2011. This announcement was released Sept. 27, 2011 from the agency headquarters in Silver Spring, Md...more on Yaz Blood Clots
FDA ANNOUNCES SAFETY REVIEW OF ZOFRAN
The Food and Drug Administration has announced that it has notified health care professionals and patients of an ongoing safety review and labeling changes for the anti-nausea drug Zofran (ondansetron, ondansetron hydrochloride and generics).
FDA officials said 0ndansetron may increase the risk of developing prolongation of the QT interval of the electrocardiogram, which can lead to an abnormal and potentially fatal heart rhythm, including Torsade de Pointes. The FDA said patients at particular risk for developing Torsade de Pointes include those with underlying heart conditions, such as congenital long QT syndrome, those who are predisposed to low levels of potassium and magnesium in the blood, and those taking other medications that lead to QT prolongation.
Zofran (ondansetron) is in a class of medications called 5-HT3 receptor antagonists. It is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery. The FDA is requiring GlaxoSmithKline to conduct a thorough QT study to determine the degree to which Zofran (ondansetron) may cause QT interval prolongation.
The FDA said labels are being revised to include a warning to avoid use in patients with congenital long QT syndrome because these patients are at particular risk for Torsade. Recommendations for ECG monitoring in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or in patients taking other medications that can lead to QT prolongation, are being included in the labels.
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 announcement was made Sept. 16, 2011 from FDA headquarters in Silver Spring, Md.
FDA ANNOUNCES WARNING UPDATE OF TNFa BLOCKERS
The Food and Drug Administration has notified health care professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. Agency officials also announced that the Boxed Warning and Warnings and Precautions sections of the labels for all of the TNFα blockers have been revised so that they contain consistent information about the risk for serious infections and the associated disease-causing pathogens.
Patients treated with TNFα blockers are at increased risk for developing serious infections involving multiple organ systems and sites that may lead to hospitalization or death due to bacterial, mycobacterial, fungal, viral, parasitic, and other opportunistic pathogens, the FDA said.
The class of TNFα blockers are used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis.
The FDA is recommending that the risks and the benefits of TNFα blockers should be considered prior to initiating therapy in patients with chronic or recurrent infection and patients with underlying conditions that may predispose them to infection. See the Drug Safety Communication on the agency Web site for a listing of recommendations for health care professionals and patients, as well as a data summary.
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 announcement was made Sept. 7, 2011 from the agency headquarters in Silver Spring, Md.
FDA WARNS OF DEATH RISKS WITH SHOULDER MASSAGER
The Food and Drug Administration is notifying health care professionals and consumers about serious health risks posed by the ShoulderFlex Massager. The agency said it has become aware of reports to the Consumer Product Safety Commission of one death and one near-strangulation associated with the ShoulderFlex Massager. The FDA said these incidents occurred when a necklace and clothing became caught in a piece of the device that rotates during use. Two other reports involved clothing and hair became caught in the device.
The ShoulderFlex Massager, distributed by King International, is a personal massage device designed for home use to provide deep tissue massage to the neck, shoulder and back while the user lies on a flat surface. King International has distributed 11,934 devices since Oct. 18, 2003. The devices were sold at various stores and online retailers in the United States.
The FDA is recommending that the use of the ShoulderFlex Massager be discontinued and also is recommending that the device components be disposed of separately so that the massager cannot be reassembled and used. The FDA is evaluating King International's plan for recall of the ShoulderFlex Massager, which may lead to additional action or communication by the FDA or King International.
FDA WARNS OF NEW AVANDIA CONCERNS
The Food and Drug Administration has issued a safety announcement to inform the public about new restrictions to the prescribing and use of rosiglitazone-containing medicines such as Avandia because of an increased risk of the drug causing heart attacks. These medicines to treat type II diabetes are also sold under the names Avandamet, and Avandaryl. Health care providers and patients must enroll in a special program in order to prescribe and receive these drugs.
The FDA said the new restrictions are part of a Risk Evaluation and Mitigation Strategy (REMS)-a program FDA may require to manage serious risks of marketed drugs. The agency said the restrictions are based on data that suggested an elevated risk of heart attacks in patients treated with rosiglitazone.
The FDA said it has modified the REMS for Avandamet and Avandaryl because previously, the REMS consisted of only a Medication Guide. The REMS, which now includes a restricted access and distribution program, applies to all three rosiglitazone products.
Health care providers and patients must be enrolled in the Avandia-Rosiglitazone Medicines Access Program in order to prescribe and receive rosiglitazone medicines. Rosiglitazone medicines will no longer be available through retail pharmacies after Nov. 18, 2011. Patients who are enrolled in the Avandia-Rosiglitazone Medicines Access Program will receive their medicine by mail order through specially certified pharmacies participating in the program.
