FDA panel vote to keep diabetes drug available
U.S. health experts recommended Wednesday that GlaxoSmithKline's (GSK) diabetes drug Avandia still be sold despite the heart attack risk it poses to patient.
A 33-member Food and Drug Administration panel voted 20-12 in favor of keeping the drug on the market. One abstained.
Most of the panel members said the drug should be restricted or used only when other diabetes drugs are ineffective.
The recommendation is subject to final approval by the FDA.
Several panel members believe that existing clinical data on Avandia were not enough to warrant the removal of the drug from market shelves.
Avandia's label already warns of cardiovascular risk. But whether it is riskier to use than other diabetes drug was the issue being tackled by the FDA panel.
The drug used to be GSK's top seller until 2007, when its side effects was exposed by Cleveland Clinic cardiologist Steven Nissen an article in the New England Journal of Medicine.