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Avandia was approved in 1999 for treatment of type 2 diabetes.
Minneapolis, St. Paul Pharmaceutical Drug Injury Lawyers, Lord & Faris Can Help you Evaluate Your Avandia Claim. 1-612-333-LORD.
March 3, 2010
Breaking News — The Food and Drug Administration (FDA) has issued a BLACK BOX warning for Avandia.
This drug increases the risk of HEART ATTACK by 43% and the risk of DEATH from Cardiovascuar Conditions by 64% — New England Journal of Medicine.
Recent Problems with Diabetes Drug Highlights Need for Stricter Enforcement, Patient Advocates for those struggling with Type 2 Diabetes say the recent reports of problems with Avandia should raise significant concerns. Avandia, marketed by the pharmaceutical company GlaxoSmithKline, is used as a standalone drug used to reduce insulin blood concentrations and has been the subject of controversy almost from the moment it was introduced to the marketplace. Recent reports from The New York Times and other news organizations suggest that controversy is not easing any time soon.
According to The New York Times, confidential government reports, including one issued by the Food and Drug Administration recommend removing the drug from the market after repeated findings that those taking Avandia suffer increased chances of heart attack and heart failure. In fact, the report states that if every diabetic who is now taking Avandia would switch to a similar medication, approximately 500 heart attacks and 300 cases of heart failure a month would be avoided. Last year alone over 300 deaths were linked to the use of the drug.
In many ways Avandia is a perfect example of what is wrong with our current regulatory scheme. At one time Avandia was one of the biggest-selling drugs in the world, with over $3.0 billion in sales in 2006 alone. The next year a report from the widely-respected Cleveland Clinic suggested that Avandia caused heart damage, including heart attacks.
The FDA learned of additional concerns in 2008 but failed to make those concerns public until just now. Some agency officials even overruled those concerns, siding with the manufacturer that the evidence failed to conclusively establish an increased risk of heart failure or heart attack for those taking Avandia. That internal struggle within the FDA is all too common when agency regulators whose job it is to monitor the safety effects of medications have less power than those who approve medications for sale on the market. It’s a problem the FDA has yet to adequately address.
Some cynics suggest that GlaxoSmithKline is simply trying to run the clock out on this particular medication. The patent on Avandia expires in 2014 at which point generic alternatives to the drug would be made available and possibly swallow any profits to be made. In efforts to satisfy regulators, GlaxoSmithKline has agreed to initiate further studies of the drug.
Even more troubling is a history of pressuring doctors and regulators early in the launch of Avandia. Both The New York Times and Senate investigators uncovered a pattern of silencing communication and influencing clinical trials. According to The Times, GlaxoSmithKline knew of the increased heart risks from the outside and did everything it could to avoid disclosing those risks. Hints of this knowledge appear in various company-sponsored clinical trials. Manufacturers would dismiss these risks because some of the information came to light during litigation and were therefore not trustworthy. Needless to say, we disagree.
Oftentimes litigation is the only way manufacturers are forced to meet their duties to the public. In this case GlaxoSmithKline has at least two duties to consumers–the duty to manufacture a product that is safe and a duty to disclose any information it has that its product is not safe. By every indication they failed at this simple job. This is only made worse when the government, who is charged with protecting the public from this very kind of abuse, is asleep at the wheel.
At Lord & Faris it’s our job to make sure your rights are protected when others don’t do theirs. If you or a loved one has taken Avandia be sure and talk to your doctor to make sure you are not one of the many suffering needlessly as a result and then come talk to us. We’ll make sure both GlaxoSmithKline and the F.D.A. understand that profits should never come before lives.
Were you injured by a defective drug or supplement? If so, please save the product and instructions for the product. Also, if you have the box the product came in that would be helpful. All of this information may be vital to proving your case.
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