May 24, 2007UNC doctor informed FDA about Avandia side effects in 2000
Dr. John Buse of the University of North Carolina is president-elect of the American Diabetes Association. Seven years ago, he wrote a letter to the Food and Drug Administration that warned the agency about Avandia side effects and their heart risks. In his letter, Dr. Buse claimed to have seen several heart-related deaths and other health problems among patients who took the blockbuster diabetes drug made by GlaxoSmithKline.Dr. Buse described Avandia patients as being subject to “a worrisome trend in cardiovascular deaths and severe adverse events.” Furthermore, he accused British-based GSK of abusing clinical trial data. The FDA did send the company a warning letter which stated that its sales reps had minimized the risk of the side effects of Avandia. GSK, in turn, was compelled to mail out a dear-doctor letter warning about the risks of the drug.
News that the incoming president of the ADA had sent the agency a warning letter in 2000 closely coincides with a study published in the New England Journal of Medicine. Conducted by Dr. Steven Nissen of the Cleveland Clinic, it found that people taking Avandia are at a 64% greater risk of heart-related death and 43% greater risk of heart attack. The FDA has announced plans for an advisory committee to look at the risk of Avandia side effects. Nevertheless, the agency has not yet issued an Avandia recall.
Many patients who have taken the popular diabetes drug have contacted an attorney to discuss filing an Avandia lawsuit, several prominent Avandia lawyers say. According to estimates by some Avandia attorneys, the total damages from Avandia lawsuits could stretch into tens of billions of dollars.