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Published on 13 July 2009

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Effient passed with warning by FDA

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Eli Lilly’s blood thinner Effient has finally been approved in the US by the Food and Drug Administration (FDA) – but it must carry the agency’s most urgent health warning.

That is because of the risks of “significant, sometimes fatal, bleeding” despite being better than Plavix at preventing dangerous blood clots that can lead to heart attack or stroke.

Approval means that Effient is the the first real competition to Plavix, the world’s second-best selling treatment that is manufactured by Sanofi-Aventis and Bristol-Myers Squibb.

Studies show that 7% of patients taking Effient experienced non-fatal heart attacks, compared with 9.1% for Plavix. The actual rates of death were similar for both drugs.

Dr John Jenkins, FDA’s director of new drugs said: “Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug.”

The drug should not be taken by patients with a history of bleeding, stroke or who are undergoing surgery, he said.

Copyright Press Association 2009

Effient



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