Avandia_fda_restriction

Avandia_fda_restriction

The use of frequently prescribed diabetes drug Avandia will be severely restricted in the U.S., the Food and Drug Administration (FDA) announced Thursday. The European Medicines Agency announced the same day that it will remove the pharmaceutical from that region’s market altogether. The new regulations will be set in place over the coming few months.

Findings that the drug, also known as rosiglitazone, increased the risk of heart attack, stroke or other cardiovascular problems have been surfacing over the years. A 2007 meta-analysis published in The New England Journal of Medicine, found “significant increase in the risk of myocardial infarction” and of death from other heart-related issues. A government investigation into Avandia-maker GlaxoSmithKline’s records showed that the pharmaceutical company had been trying to hide its evidence that the drug might be less safe than the competitor Actos. Based on these findings and other evidence, an FDA advisory panel recommended in July that Avandia be limited.

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