Controversy Rages Over Diabetes Drug's Heart Risks

FDA official says superiors ordered her to back off serious warning
By Mary Papenfuss,  Newser Staff
Posted Jun 6, 2007 12:16 PM CDT
Controversy Rages Over Diabetes Drug's Heart Risks
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(Newser) – Troubling questions about the diabetes drug Avandia persisted yesterday as an FDA official revealed that she was barred from recommending a critical warning about the medication, the Times reports. In the run-up to congressional hearings that began today, manufacturer GlaxoSmithKline rushed to disseminate interim clinical findings in hopes of blunting the controversy.

A recent study determined that Avandia could increase heart attack risk by 43%: GSKs own trials found fewer heart deaths among users than a control group. The FDA is drawing fire for not making the drug's cardiovascular risks clearer, and the official who was ordered to drop a recommendation for a "black box" warning said she was punished for raising concerns. (Read more Avandia stories.)

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