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Prilosec, Nexium don't elevate risk of heart trouble, FDA says

December 11, 2007|From Reuters

WASHINGTON — U.S. regulators said Monday that they had cleared AstraZeneca's bestselling heartburn drugs Prilosec and Nexium of links to heart problems, but disclosed a review of a potential risk of hip fractures.

The Food and Drug Administration concluded the drugs had no negative effect on the heart, an issue under scrutiny after two small studies suggested a greater risk of heart attacks, heart failure and heart-related sudden death from the drugs than from surgery to remedy severe acid reflux disease.

FDA officials also revealed results of a separate agency examination of hip fracture risk potentially associated with the class of drugs to which Nexium and Prilosec belong.

Last December the Journal of the American Medical Assn. reported on a study suggesting that long-term use of the drugs increased the risk of hip fractures in adults over 50.

"Internally we've looked at the issue and we've asked the sponsors to send additional information and analysis," Joyce Korvick, deputy director in the gastroenterology unit at the FDA, said in response to a question. "That is under review."

AstraZeneca spokesman Blair Hains said that the firm, based in London, supplied the FDA with data on the fracture issue and that the drugs' long track record did not show a link.

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