Recommendation To Keep Avandia On Market Despite Heart Risks

Jamie Sheller

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Members of two FDA advisory panels had a joint meeting recently to vote on Advandia. The drug is made by GlaxoSmithKline and is used to treat diabetes. In a vote of 22 to 1, the advisors recommended that Advandia stay on the market. The FDA advisors recognized that Advandia increases ischemic heart risks for patients with type 2 diabetes. Even though the vote was overwhelmingly to keep the drug on the market, in light of the heart risks, the advisors believe that Advandia's market should be narrower. According to them, Advandia should not be used by patients with a history of coronary heart disease, congestive heart failure, patients requiring insulin or who are long-term users of nitrates. Members of the two panels also want additional warnings on Advandia. Though the FDA is not required to accept the recommendations of advisory panels, it usually does.

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