The Food and Drug Administration Nov. 25 announced it is requiring the removal of certain restrictions on the prescribing and use of GlaxoSmithKline’s diabetes drug Avandia (rosiglitazone) to reflect new information on the drug’s cardiovascular risk.
The agency said that results from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) clinical trial showed no elevated risk of heart attack or death in patients being treated with Avandia when compared to standard-of-care diabetes drugs.
These data don’t confirm the “signal of increased risk of heart attacks” that was found in a meta-analysis of clinical trials first ...
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