US Pharm. 2010;35(8):6.
Gaithersburg, MD—An FDA advisory panel has voted to keep Avandia (rosiglitazone) on the market despite concerns over increased heart attacks among patients. The type 2 diabetes drug is manufactured by GlaxoSmithKline (GSK) and has included a black box warning regarding heart failure since 2007. This ruling will require additional warnings to be added to the drug’s labeling. The panel also voted to recommend continuation of the TIDE trial, which compares GSK’s Avandia with Takeda Pharmaceutical’s Actos (pioglitazone). In addition, GSK has agreed to pay $460 million to patients to settle a class action suit over Avandia. “Patients taking Avandia should speak with their physician about their treatment and any questions they may have regarding the safety of the medicine,” Ellen Strahlman, MD, GSK’s Chief Medical Officer, said in a statement.
