FDA considers label changes for some bone drugs

The U.S. Food and Drug Administration said on Tuesday it may require a class of osteoporosis drugs known as bisphosphonates to carry new information related to unusual femur fractures.

The FDA’s statement follows the release of a report from the American Society of Bone and Mineral Research (ASBMR), which the agency said provides “important perspectives” on the potential association between long-term treatment with bisphosphonates and a rare but serious type of fracture of the thigh bone, or femur.

The bisphosphonate class includes Fosamax, Boniva, Reclast and Actonel.

Ronald Rogers, a spokesman for Merck, who makes Fosamax, said that in clinical studies involving more than 28,000 patients, Fosamax has not been associated with increased fracture risk at any skeletal site.

“Since bisphosphonates were first approved for the treatment of osteoporosis in 1995, millions of people, primarily women, have been treated,” he said in an email.

Officials at Roche, Novartis and Warner Chilcott, makes of the other drugs, were not immediately available for a comment.

The FDA said the report from the ASBMR includes a case definition that describes the atypical features of these unusual femur fractures, which it believes will help in identifying cases and reporting on them.

“Although it is not clear if bisphonsphonates are the cause, these unusual femur fractures have been identified in patients taking these drugs,” the agency said. “FDA recommends that healthcare professionals be aware of the possible risk of unusual femur fractures in patients taking bisphosphonates.”

The FDA said recommendations from the ASBMR’s Task Force include changes to product labels alerting healthcare professionals and patients to the possibility of unusual femur fractures with long-term use of the drugs.

The agency said it is thoroughly reviewing all long term data available on the products, as well as safety reports, and is considering label revisions.

The FDAs statement was made on its website at: http://www.fda.gov/Drugs/DrugSafety/ucm225681.htm.

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BOSTON (Reuters)