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Study Reconfirms Dangers of Diabetes Drug Avandia; FDA Should Ban It

Nov. 24, 2008  

Study Reconfirms Dangers of Diabetes Drug Avandia; FDA Should Ban It

Statement of Sidney Wolfe, M.D., Director of the Health Research Group at Public Citizen

A study published today underscores the dangers associated with the popular diabetes drug Avandia and the need for it to be immediately pulled from pharmacy shelves. The study, published in the Archives of Internal Medicine, involved 28,000 Medicare beneficiaries older than 65, half of whom had started taking Avandia, half a related drug, Actos. Researchers found a 15 percent excess overall death rate in those taking Avandia compared with those taking Actos. The authors stated that “This study confirms the safety concerns that have been raised for [Avandia] compared with [Actos], which, in turn, also cannot be considered a very safe drug given its well-documented effect on the risk of CHF [congestive heart failure].”

This study should be the last nail in the coffin of a drug that we petitioned the FDA to ban last month and that the American Diabetes Association recommends not to use. There is no doubt that Avandia has killed or injured more people than it has benefited. Were the FDA to behave as though it is really a part of the U.S. Public Health Service, it would immediately ban this drug.

The study is titled, “Comparison of Cardiovascular Outcomes in Elderly Patients With Diabetes Who Initiated Rosiglitazone vs Pioglitazone Therapy,” by Wolfgang C. Winkelmayer, M.D., ScD; Soko Setoguchi, M.D., DrPH; Raisa Levin, M.S.; Daniel H. Solomon, M.D., MPH.

Read Public Citizen’s petition