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FDA Panel votes not to remove rosiglitazone from the market albeit with more restrictions

In a surprise decision on rosiglitazone, advisors to the FDA have recommended keeping rosiglitazone on the market, though most did recommend stricter warning labels. The FDA will now decide which course to take. Six votes were taken by the 33 members of the panel on various issues. The voting pattern was as follows: 12 voted for the drug to be withdrawn;10 voted that for restricting its sales and enhancing warnings warnings on its label; 7 voted only to support enhanced warnings on the drug’s label; and 3 voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, to weaken the label’s present heart warnings. Dr. Janet Woodcock, director of the FDA’s drug center said that the agency is looking seriously at the recommendations of the panel and would consider its regulatory options.

Dr KK Aggarwal
Editor in Chief