Avandia to Stay, says FDA Panel
Updated August 2007: A federal drug advisory committee voted 22 to 1 on July 30 that GlaxoSmithKline’s Avandia should remain on the market; although the committee also voted 20 to 3 that the diabetes drug raises the risk of heart attack.
Committee members decided that the studies on Avandia were not definitive enough to make drastic regulatory action, and that other diabetes medications could pose similar risks.
Panelists recommended that the drug’s label should include a “black box” warning and some suggested the label should caution against using the drug in conjunction with insulin because the drugs used together may elevate heart risks. Other members called for more long-term studies and studies that focused on specific patient groups, such as older diabetics or those who take insulin.
The FDA is not required to follow the recommendations of the advisory panel, but the agency usually does.
GlaxoSmithKline told the committee that it does not believe that Avandia increases the risk of cardiovascular illness or heart attacks, and that ordering “black box” warnings on Avandia’s label may have patients taking different and more dangerous drugs.
Many FDA researchers do not agree with the panel’s decision. "It is important that the committee understand there is a fundamental disagreement within (the FDA's drugs office) on the scientific conclusions that should be drawn," said Dr. Robert Meyer, head of the FDA office that reviews new diabetes drugs.
The FDA moved up the date of the meeting after a study was published in the New England Journal of Medicine that generated new concerns about Avandia’s safety. The analysis of 42 studies revealed that users of Avandia have a 43% higher risk of heart attack than those taking other diabetes drugs or no diabetes medication at all.