FDA Approves the Sale of Avandia: Advantages Outweigh the Risks

This week a research panel made a recommendation to the FDA that the diabetes drug Avandia should be removed from sale or either sales should be limited. The drug supposedly increases the risk of heart attacks in patients.

The maker of the drug, GlaxoSmithKline, has come under fire from the FDA recently for not disclosing the possible side effects of the drug. The initial recommendation was to remove the drug from the shelves completely but the FDA has decided to continue sales. The FDA made the decision after the panel voted 20-12 to keep the drug on the market. The drug will stay on the market but with a warning label attached to the prescription bottle describing the possible risks of heart ailments.

Typically, if an advisory board recommends that a drug be removed from the market or not, the FDA will follow their decision. Of course, the FDA is not required to go along with their recommendation; however, in this case they felt that the advantages far outweighed the risks of the drugs.

Ellen Strahlman, GlaxoSmithKline main medical officer, stated publicly yesterday that the company will continue to work in cooperation with the FDA to improve the lives of patients suffering from diabetes.