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Osteoporosis Drugs Like Fosamax Can Stop After Five Years

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Following its review of Fosamax, the U.S. Food and Drug Administration (FDA) has determined that women taking Fosamax and other bone strengthening medications known as oral bisphosphonates can, for the most part, safely stop taking the drugs within five years.

According to the FDA staff report, said the New York Times, which has been released prior to meeting of two of its scientific advisory committees, research reveals that while osteoporosis medications offer benefits in fracture prevention in the first three years of treatment, the benefits diminish after five years. As a matter-of-fact, continuing to take medications such as Fosamax after five years does not offer benefits over no drug treatment, according to the report, said the Times.

Oral bisphosphonates include the medications Fosamax, Actonel, and Boniva, that are typically prescribed for the treatment or prevention of osteoporosis in post-menopausal women. The FDA reports that about 5 million Americans use oral bisphosphonates.

“These results suggest no significant advantage of continuing drug therapy beyond 5 years,” said the agency’s review, according to the Times. “The safety of long-term bisphosphonate therapy continues to be unclear as study results are conflicting,” the report stated, added the Times.

The FDA had not previously conducted what the Times described as a broad review of specific oral bisphosphonates’ long-term safety and efficacy. Now, Merck’s Fosamax, which received FDA approval in 1995 are under review along with Roche Therapeutics’ Boniva; Actonel and Atelvia, which are manufactured by Warner Chilcott; and some generic versions, said the Times.

Side effects that may be linked to long-term use of oral bisphosphonates include dead jaw syndrome, atypical femur fractures, and esophageal cancer. In 2005, the FDA mandated bisphosphonate labels be updated to include warnings regarding dead jaw syndrome. Last year, warnings were added regarding thigh fractures, and just this past summer, the FDA said it was continuing its review of esophageal cancer in patients taking oral bisphosphonates.

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