FDA Says Mercks Fosamax Drug May Lead to Pain

posted on:
January 7, 2008


Readington-based Merck & Co.’s Fosamax, Novartis AG’s Reclast and similar medicines for thin, weak bones may produce severe joint and muscle pain, U.S. regulators said.

Health-care professionals should consider discontinuing use of the treatments, called bisphosphonates, in patients who develop pain, the Food and Drug Administration said today in a statement on its Web site. The side effect is already listed in the drugs’ prescribing information, though it may be missed by doctors, the FDA said.

About 10 million Americans, mostly older women, have the loss of bone density known as osteoporosis. Demand for new, more convenient treatment options has increased as the U.S. population ages. Market leader Fosamax, with sales of $3.1 billion in 2006, will face generic competition this year. Reclast, a 15-minute infusion given once a year, was approved by the FDA in August.

Procter & Gamble Co.’s Actonel and Didronel, Novartis’s Aredia and Zometa, Sanofi-Aventis SA’s Skelid, and Boniva, sold by Roche Holding AG and GlaxoSmithKline Plc, were also named in the FDA’s statement. The agency plans to provide doctors with more information after it reviews the risk of joint pain associated with the products during the next six months.

The FDA said in October that it was reviewing bisphosphonates for a possible link to irregular heart rhythm after a study showed that women taking Fosamax or Reclast were more likely to develop serious cases of atrial fibrillation.

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