GlaxoSmithKline (GSK) has responded to Public Citizen’s petition to the FDA to ban its diabetes drug Avandia (rosiglitazone maleate) because it can cause death from liver failure.
“The safety of patients using our medicine is very important to us,” GSK said in a statement. “On a continual basis, an external Hepatic Safety Board reviews any adverse event report received by GSK of liver failure, liver-related deaths, and liver transplants for possible relationship to Avandia. As recently as July 2008, this panel of experts continued to endorse a favorable hepatic safety profile for Avandia.”
In its October 30 petition, the consumer group said it has identified 14 cases of Avandia-induced liver failure, including12 deaths. These cases were derived from the FDA’s Adverse Event Reporting System. Also in October, representatives from a joint medical panel of the American Diabetes Association and the European Association for the Study of Diabetes unanimously advised against using Avandia because of their concerns about the drug’s risk. The consensus statement is published online on the Diabetes Care Web site.
The FDA said it will carefully review the petition. GSK received FDA approval for Avandia in 1999.
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