News Tagged ‘rosiglitazone’

FDA panel to decide fate of diabetes drug Avandia

avandiabottle 100x100The fate of the drug Avandia will likely be decided soon by an expert panel that has spent the past two days reviewing evidence that linked the drug to serious cardiovascular events and whether its developer and manufacturer, (GSK), influenced the results of a study asserting the safety of .

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FDA announces it will review studies linking Avandia to heart attacks

fda logo 100x100It’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 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 (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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Doctors and critics doubt the accuracy of Avandia study

avandiabottle 100x100Results 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 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 ’s one-time blockbuster drug a sales boost.

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