Avandia Lawsuit & Settlement Attorney Class Action
Our law firm is currently investigating claims involving the use of Avandia and death, heart attack, congestive heart failure as well as fractures in the hands and feet. There are potential Avandia class action lawsuits starting and compensation from a settlement may occur. If you or a loved one has taken Avandia and experienced any of the above situations, please contact the Avandia lawyers and attorneys at our firm today.
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Avandia News: Possible Lawsuits and Recall
FDA Warning 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.
FDA to severely limit access to Avandia.
Both the FDA and European Drug regulators have announced a joint effort to restrict the sales of Avandia.
Avandia sales will be halted completely in Europe, but patients in the US will be allowed access to Avandia only if they and their medical professionals can attest that they have tried every other diabetes medicine and that patients have been made aware of the drugs substantial risks to the heart.
Requiring patients and doctors to meet certain criteria in order to get the drug should cause people to really question this dangerous drug before using Avandia. This should hit GlaxoSmithKline hard, as sales will be restricted. GlaxoSmithKline has made huge profits from Avandia, (1.9 billion last year) it seems that time is now over.
New Avandia Research shows link to heart attacks.
Avandia maker GlaxoSmithKline now agrees to pay 460 million to resolve a majority of the pending lawsuits against the manufacturer. The lawsuits allege that Avandia can cause heart attacks and strokes.
Doctor Steven E. Nissen, a Cleveland Clinic cardiologist, did a study of more than 35,500 patients found that Avandia significantly raises the chances of a heart attack.
In one of the new analysis, Nissen and a colleague pooled data from 56 studies involving 35,531 patients, including 19,509 who took Avandia. In a paper released online by the Archives of Internal Medicine, the researchers concluded the drug increased the risk for heart attacks from 28 percent to 39 percent. The pair calculated that the drug would cause one heart attack among every 37 to 52 patients who used it for five years.
The second study was a federal analysis of more than 227,500 Medicare patients and found the drug boosts the risk for strokes, heart failure and death."There's no reason to keep this drug on the market," said Steven E. Nissen, a Cleveland Clinic cardiologist who conducted one of the analyses and has long criticized the drug. "This is a harmful drug."
WASHINGTON – Senator Max Baucus, Chairman of the Committee on Finance, and Senator Chuck Grassley, Ranking Member, today released a committee report based on a two year inquiry of the diabetes drug Avandia. The senators also asked the Food and Drug Administration to describe what steps the agency has taken to protect patients in an ongoing Avandia clinical trial, and why the study is allowed to continue, given that the FDA itself estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007. In 2008, FDA officials called the clinical trial, as then-designed, “unethical and exploitative” of patients.
“Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them. Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust,” Baucus said. “We will continue watching closely and working with the FDA to make sure patients and doctors are aware of the risks associated with Avandia and all drugs so they can make safe and informed decisions when choosing their medicines.”Full publication at: http://finance.senate.gov/press/Gpress/2010/prg022010.pdf
The first study and overall analysis of scientific evidence released in 2007 found rosiglitazone (Avandia) increased the risk of cardiovascular disease and heart attack, which led many doctors and patients to discontinue use of the drug.
Of the diabetes patients in this new study, 89 percent were using combination therapy before discontinuing use of rosiglitazone. After discontinuation, 33 percent of patients were on combination therapy. Another 13 percent of patients weren't prescribed any diabetes medications.
Avandia Safety Questions.
The government announced Wednesday that the 10,000 patient ACCORD clinical trial involving diabetes treatment has been halted 18 months early due to increased risk of patients death. The trial was stopped after the Data Safety and Monitoring Board found that the rigorous treatment increased the patients’ risk of death by 25%.
The results bring into question the methods used of lowering blood sugar actually protects the heart and is very likely to call the safety of the diabetes drug Avandia into question, yet again.
Although the research does not indicate a link between Avandia use and increased deaths, Steve Nissen, who linked Avandia use to increased risk of heart attacks, states, “ "It's very hard to sort out," and "We've got to be careful not to jump to conclusions.". Nissen went on to say "Clinicians have been taught that getting to lower blood sugar is better” and “its really going to shake things up”.
Avandia was recently back in the news, when it was found that Dr Steven Haffner, admitted leaking information about a study linking the drug to a 43% greater risk of heart attacks to GlaxoSmithKline PLC 17 days before the article was published in the New England Journal of Medicine, last May.
Update: A new study was done on the effects of Avandia by Dr. Merri Pendergrass and presented at the 2009 American Diabetes Association Scientific Sessions. The study was looking at the increased rate of bone fractures of people who were taking Avandia. This study showed that fractures increased by 40% for patients taking Avandia (rosiglitazone).
FDA scientist has declared that the diabetes drug Avandia should be pulled from the market due to heart risks.
Dr. David Graham in a slide presentation illustrated that Avandia is no more affective in treating diabetes then other medications currently available on the market. Because of the known heart risks from taking Avandia he recommends it be taken off the market.
The presentation was at the beginning of a daylong meeting of a joint panel of outside experts brought together to consider whether the drug should be restricted to use in select patients and labeled with prominent warnings or removed altogether from sale.
Previously, the FDA said information from dozens of studies of the GlaxoSmithKline PLC drug points to an increased risk of heart attack.
Public Citizen Agency asked for heart failure to be noted on Avandia labels.
Consumer advocacy group Public Citizen has released a memo a day after researchers announced Avandia or rosiglitazone increases the risk of cardiovascular-related death by 64 percent and the risk of heart attack and related heart injury by 43 percent.
In the memo Pubic Citizen stated that U.S. health authorities were well aware of heart risks linked to GlaxoSmithKline diabetes drug Avandia and another competitor nearly five years ago.
In 2002, The FDA scientists called for reports of congestive heart failure to be noted on the labels of Avandia and Actos, made by Takeda Pharmaceutical Co. Ltd., citing an internal FDA document. More on Actos lawsuit
The head of Public Citizen’s Health Research Group Dr. Sidney Wolfe stated the 2002 memo illustrated that the FDA failed to take its own staff scientists seriously.
To quote Dr. Wolfe: “As a result, millions of people, to the detriment of their health, are prescribed drugs whose risks are dangerously understated, instead of being prescribed safer, equally or more effective alternative drugs."
Dr. Wolfe wrote a letter to FDA Commissioner Andrew von Eschenbach asking the agency to issue the highest possible warning a drug can have, a black box warning, for both Avandia and Actos, or to even ban them altogether.
In the letter Dr. Wolfe wrote: “There continues to be no mention of the large and increasing number of post-marketing reports of heart failure, which was the explicit recommendation in the 2002 internal FDA memo.”
Related news on Avandia: Three medical organizations have issued a joint statement saying diabetes patients should stay on their medications until they speak to their doctors.
Avandia Heart Attack Risks Study
A pooled study on GlaxoSmithKline’s Avandia drug released by the New England Journal reflects health implications for diabetic patients.
A cited finding reflects data from 42 studies involving 15,560 patients who took the drug and 12,283 patients who were given other medications or a placebo. Patients getting Avandia were 43 percent more likely to have a heart attack. The study suggested trends toward higher death rates in the Avandia study group.
``The results of this analysis raise serious concerns about the cardiovascular safety'' of Avandia, known chemically as rosiglitazone, said Steven Nissen, the chairman of cardiology at the Cleveland Clinic in Ohio. ``Unfortunately, rosiglitazone appears to increase, rather than decrease, the most serious complication of diabetes, heart disease.''
American Diabetes Association reports that almost 21 million people in the U.S. have diabetes, a disease in which the body doesn't properly make or use the hormone insulin to convert blood sugar to energy. There have been tens of millions of prescriptions for Avandia written since approved in 1999.
Avandia acts by lowering the body’s blood sugar levels, which can cause complications including kidney and eye damage, by increasing the body's sensitivity to insulin.
Prior Studies in the US have shown a total of 158 heart attacks and 61 deaths from cardiovascular causes among the patients in the studies, which generally lasted from six months to a year.
First approved by the Food and Drug Administration in 1999, Avandia is a drug designed by GlaxoSmithKline intended to treat type II diabetes. This condition, commonly called adult-onset diabetes, affects millions of people across the world.
Diabetes type II is characterized by insulin resistance, which means that the insulin in the body does not absorb glucose in the blood stream.
Avandia helps these patients moderate the amount of sugar in their body in order to prevent the serious complications type II diabetes can cause such as:
- Heart attack risks (Congestive heart failure Leaking heart injury)
- Renal failure
- Coronary artery disease
- Slow healing wounds
Avandia dangerous and potentially-fatal side effects to the liver including:
- Jaundice (yellowing of the eyes and skin)
- Dark urine
- Loss of appetite
- Stomach pain
These side effects should be treated immediately by medical professionals as they could be signs of serious liver damage.
Furthermore, Avandia is also linked to heart failure and hypoglycemia, or extremely low blood sugar.
Heart failure symptoms include
- Chest pain
- Swelling of the extremities
- Weight fluctuations
- Difficulty breathing/Shortness of breath
Hypoglycemia symptoms include:
- Accelerated heart rate
Injured or hurt from taking Avandia:
If you or someone you love was affected by congestive heart failure, leaking heart injury from Avandia, you may be entitled to financial compensation from an Avanida class action lawsuit settlement for your situation. Let our experienced and aggressive defective drug attorneys help you get the justice you deserve. Contact our Avandia Lawyers and attorneys today.
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