On September 23, 2010, The Food and Drug Administration (FDA) announced that it will significantly restrict the use of the popular diabetes drug, Avandia. FDA reports indicate the restrictions are the direct result of multiple studies suggesting that Avandia consumers have a greater risk of experiencing cardiovascular problems, including heart attack and stroke.
Indeed, this is not the first time the FDA has expressed concern for the drug, manufactured by GlaxoSmithKline and generically known as Rosigilitazone. In 2007, the FDA issued a “black box” warning indicating that Avandia consumers may be at risk of heart attack. Earlier this year, the N.Y. Times also reported that, pursuant to confidential government reports, if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month.
Despite this alarming data, the FDA has decided that Avandia will not be taken off the market. Instead, Thomas H. Maugh II and Andrew Zajac of the Los Angeles Times report that patients currently taking Avandia will have to sign an informed consent statement acknowledging that they understand all the risks before they will be allowed to refill their prescriptions. New patients will not be able to receive the drug unless their doctors certify that alternative therapies and treatment methods will be unable to control the patients’ blood sugar levels.
Taking Avandia off the market, may just be a matter of time. “The FDA has been too cozy with drug makers and has been regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks,” said Senators Baucus and Grassley in their committee report on Avandia.
For now, however, and until the FDA decides Avandia must be taken off the market, the drug continues to be one of the most widely used oral diabetes treatments, with 2009 sales of 1.2 billion.