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.
But the evidence is still being debated, with some experts suggesting that the drug might be an important treatment for some type 2 diabetes patients for whom other drugs have been less successful.
Some 600,000 people in the U.S. take Avandia, which was first approved by the FDA in 1999, and most of them will be allowed to continue if they and their doctors decide it is the best option. "We heard very clearly from both providers and patients that some patients felt that they were unable to tolerate other diabetes medications and that this drug was effective for them," Margaret Hamburg, commissioner of the FDA, said Thursday, Nature reported (Scientific American is part of Nature Publishing Group).
Nevertheless, the FDA followed the advisory panel's recommendation to limit marketing of the drug—rather than introducing new labeling requirements. "Despite the lack of clarity in the data, I believe it is most prudent, given the current uncertainty about the safety risk, to restrict access to the product," Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, wrote in a September 22 memo.
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