Medical groups advise against using GlaxoSmithKline’s Avandia

Public Citizen petitions the FDA to ban the diabetes drug

11/04/08

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.

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