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Fosamax, Bisphosphonates Face FDA Review

Sep 6, 2011 | Parker Waichman LLP

A  U.S. Food & Drug Administration (FDA) advisory panel scheduled to meet on Friday could recommend that women taking Fosamax and other oral bisphosphonates take a "drug holiday" from such medications in order to avoid some serious side effects.  According to The Wall Street Journal, the FDA panel has also been asked to recommend if use of oral bisphosphonates should be limited to a few years.

Most research involving bisphosphonates has only covered about 4 or 5 years, but most women take them longer than that. It's long been assumed that such long-term use was safe.  But over the past several years, Fosamax and other oral bisphosphonates have been linked to a number of serious side effects, including a rare type of femur fracture and osteonecrosis of the jaw, or dead jaw syndrome.  There is also some evidence pointing to a possible connection between bisphosphonates and esophageal cancer, prompting the FDA to recommend further studies on that matter.

In the case of femur fractures, most of the 300 or so reported to the FDA have occurred in patients taking bisphosphonates for five years or more.  Last year, the FDA added information to the “Warnings and Precautions” section of the drugs labels’ describing the risk of atypical thigh fractures. Since then, some doctors have begun to reassess the long-term use of bisphosphonates.

"The longest anybody could have taken this drug is 15 years now," pigs," Dr. Susan Ott, author of a review of the drugs, told the New York Times. "It's an ongoing experiment, and there are a few million women in the country who are participating in it."  Ott told the Times she uses bisphosphonates in her own patients for shorter periods.

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