Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

It’s a long time coming. This week the Food and Drug Administration (FDA) announced it is reviewing the primary data from a large, long-term clinical study, known as RECORD, on possible cardiovascular risks associated with the diabetes drug Avandia (rosiglitazone). The agency said it is also reviewing on an ongoing basis a number of other published observational studies on the cardiovascular safety of the drug. The FDA’s announcement comes on the heels of news that two U.S. senators are asking why the GlaxoSmithKline (GSK) drug is still on the market when an FDA oversight board in 2008 urged the agency to pull the drug because it was causing 500 additional heart attacks a month. That request by the oversight board was based on the findings from the RECORD study.

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Results of a clinical study announced in New Orleans recently appeared to exonerate Avandia from long-held suspicions that the drug causes adverse cardiovascular events in patients undergoing treatment for diabetes 2. Many doctors and other critics, however, say that the study is flawed and remain unconvinced of the findings. Financial analysts believe the results will likely give GlaxoSmithKline’s one-time blockbuster drug a sales boost.

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