Medical experts and FDA drug safety officials claim the advisory panel that voted in July not to recommend an Avandia recall was loaded with sympathetic panelists
*** Avandia® Labeling Update 2/4/11: The FDA has notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of Avandia (rosiglitazone) has been added to the physician labeling and patient Medication Guide. Additionally, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:
- In patients already being treated with these medicines
- In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
Free Avandia Side Effects Case Evaluation: If you or a loved one has been injured by Avandia, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
What’s the problem?
September 16, 2010 – Dr. David Graham and Dr. Kate Gelperin of the FDA Office of Surveillance and Epidemiology, wrote a letter published on September 7 in the British Medical Journal saying that the Avandia advisory panel, which was supposed to consist of independent outside experts, included 16 people who were no longer active members of the normal advisory committees. All but one of those non-members who were invited to vote had already voted against removing Avandia from the market in 2007, when concerns about Avandia heart problems first became public.
The 16 members from the 2007 meeting made up half of the 32-member panel which voted 20 to 12 to keep Avandia on the market, despite acknowledging overwhelmingly that it probably increased the risk of heart attacks and other heart problems. The panel did recommend that Avandia carry stronger warnings and be more restricted in use.
Avandia (rosiglitazone) was first approved in the United States in 1998 to treat type 2 diabetes by helping control blood sugar levels. The drug has been used by millions of diabetics, but sales have plummeted in recent years as concerns grew about the increased risk of heart attacks and other serious side effects from Avandia. GlaxoSmithKline (GSK) faced about 13,000 Avandia lawsuits filed by plaintiffs who accuse the company of failing to warn patients of the drug’s heart attack risks. Last month the company announced it had reached settlements in about 10,000 of those suits.
Do I have an Avandia Side Effects Lawsuit?
The Defective Drug & Products Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Avandia side effects lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.