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Bone Drugs May Not Help Women Long Term, FDA Review Says

May 10, 2012

Bone-strengthening drugs such as Merck & Co. (MRK:US)’s Fosamax, used to treat and prevent osteoporosis in older women, may have little long-term benefit, U.S. regulators said in an analysis of previously released studies.

Research from the Food and Drug Administration, published yesterday in the New England Journal of Medicine, renews a debate about whether use of the drugs after more than three to five years provides any protection against the risk of bone fractures. The agency has been evaluating the safety of the treatments since 2007 and last September an advisory panel suggested changes to the medicines’ labels to show the effectiveness may wear off over time.

About 8 million women and 2 million men in the U.S. have osteoporosis and 34 million Americans have low bone mass that puts them at risk of the disease, according to the FDA. The agency previously linked the drugs, which include Warner Chilcott Plc (WCRX:US)’s Actonel and Roche Holding AG (ROG)’s Boniva, to thigh fractures and jawbone deterioration. It is also investigating conflicting studies that the treatments may raise the risk of esophageal cancer.

The analysis of two previous studies of 2,342 post- menopausal women “showed little benefit of continued bisphosphonate treatment beyond five years,” the FDA said in yesterday’s report.

While the agency didn’t propose specific guidelines for doctors, it suggested that women with low bone-mineral density at the highest risk of fractures may gain some benefit from continued treatment with the drugs.

Actonel had $771 million in 2011 sales (WCRX:US) for Dublin-based Warner Chilcott while Boniva generated $788 million for Basel, Switzerland based Roche. Fosamax, which faces generic competition, had sales (MRK:US) of $855 million for Whitehouse Station, New Jersey-based Merck.

To contact the reporter on this story: Andrew Pollack in San Francisco at

To contact the editor responsible for this story: Reg Gale at

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