Medical groups advise against using GlaxoSmithKline’s Avandia
Public Citizen petitions the FDA to ban the diabetes drug
In October 2008, the American Diabetes Association (ADA) and the European Association for the Study of Diabetes announced that members of a medical panel unanimously advised against using GlaxoSmithKline’s controversial diabetes drug, Avandia. The Food and Drug Administration (FDA) also received a petition from consumer advocacy group Public Citizen asking the agency to ban the drug.
Avandia’s label already has a “black box” warning identifying 14 cases of liver failure caused by the drug, 12 of which resulted in liver-related deaths. Controversy surrounding the diabetes drug began in May 2007 when cardiologist Steve Nissen of the Cleveland Clinic published an article that found Avandia patients had a 43 percent higher chance of suffering a heart attack.
GlaxoSmithKline said it does not believe there is a connection between liver toxicity and Avandia. The FDA is reviewing Public Citizen’s petition. Officials from the agency have said there is a split within the agency over pulling Avandia off the market.
Avandia is a drug designed to help lower blood sugar in patients with Type 2 diabetes. It was approved by the FDA in 1999.
Source: Jennifer Corbett Dooren, “Leading medical groups advise against Avandia,” Wall Street Journal, October 31, 2008.

