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Critics Point to Avandia When Calling for FDA Safety Reforms

Avandia, a diabetes drug manufactured by GlaxoSmithKline, is being used as an example of the need for changes in the way the U.S. FDA handles safety issues.

Drug safety reviewers recommended that the drug be taken off the market after concluding carried more heart risks than rival drugs. This has prompted calls for more power for reviewers who analyze a drug's risks after it reaches the market.

According to Reuters:

“The FDA has said it is undertaking an internal review of drug safety decision-making in addition to bringing Avandia to an advisory panel of outside experts in July. ‘This review will make recommendations regarding the agency's approach to safety issues including Avandia,’ FDA spokeswoman Karen Riley said ...”

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