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FDA panel says data does not support lower heart risk of naproxen

Tuesday, 11 Feb 2014 | 1:03 PM ET

Feb 11 (Reuters) - An advisory panel to the U.S. Food and Drug Administration voted on Tuesday that there is not enough evidence to show conclusively that the painkiller naproxen carries a lower cardiac risk than other popular products.

The panel voted 16-9 that a retrospective review of clinical data does not prove that naproxen, a drug contained in the prescription product Naprosyn and over-the-counter Aleve, carries less cardiovascular risk than rival products such as ibuprofen.

Naprosyn is made by Roche Holding, and Aleve is a product of Bayer AG.

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