Widely used osteoporosis drugs may raise the risk of an unusual type of thigh fracture, U.S. health officials warned on Wednesday.
All medicines in the class known as bisphosphonates will carry a new warning about the fractures, the Food and Drug Administration said in a statement.
The drugs, used by millions over the past decade, include Merck's Fosamax, Roche's Boniva, Novartis’ Reclast, and Warner Chilcott's Actonel. Fosamax also is sold generically under the name alendronate.
Patients, who are mostly women, take bisphosphonates to reduce the rate of fractures from the bone-thinning disease osteoporosis.
The FDA said it was not clear if the medicines caused the atypical thigh fractures, a rare and serious type, but that most cases were reported in patients taking bisphosphonates.
Doctors should reassess the need for the drugs in patients who have taken them for longer than five years, the agency said.
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