Osteoporosis drugs used by millions of women to prevent bones from breaking may increase the chances for an unusual type of thigh fracture, U.S. health officials warned on Wednesday. The drugs known as bisphosphonates include Merck & Co Inc's Fosamax, Roche Holding AG's Boniva, Novartis AG's Reclast and Warner Chilcott Plc's Actonel.
The action could drive patients to Amgen Inc's just-launched rival medicine, Prolia, a different type of osteoporosis drug that is the company's most important future growth driver.
Food and Drug Administration officials said all bisphosphonates used for osteoporosis will carry a new warning about rare but serious fractures of the thigh bone, even though it remains unclear if the medicines caused the fractures.
The agency advised doctors to consider if patients on therapy for more than five years still need the drugs. The new warning "should not cause patients taking bisphosphonates to be fearful of their medicine," said Dr. Sandra Kweder, deputy director of the FDA's new drugs office.
The drugs "are an important mainstay of osteoporosis management" and "have prevented innumerable fractures in their years of use," Kweder told reporters on a conference call.
More than 5 million U.S. patients filled prescriptions for bisphosphonates in 2009, the FDA said.
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