FDA Advisory Committee recommends modification to Avandia (GSK) restrictions
The majority of members on a FDA advisory panel have recommended modifying the restrictions placed on Avandia (rosiglitizone)from GSK.
An FDA joint advisory committee voted to continue to make the drug available to appropriate patients with the majority of the 26 members voting to either modify (13 votes) or remove (7) the strict risk evaluation and mitigation strategy (REMS) programme currently in place on the drug. Five panellists voted to continue with the REMS, while one called for a complete withdrawal from the US market. The FDA will now decide what further action to take .
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