-FDA mulls label changes for some osteoporosis drugs
3:28pm EDT
* FDA advises doctors: be aware of unusual femur fractures
* Unclear if bisphosphonates are cause of fractures
* Reviewing all long-term data on bisphosphonates
* Drug class includes Fosamax, Boniva, Reclast, Actonel (Updates with comment from Roche, background, adds byline)
By Toni Clarke
BOSTON, Sept 14 (Reuters) - 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 bisphosphonate class includes Fosamax, made by Merck & Co Inc (MRK.N: Quote, Profile, Research, Stock Buzz) and sold generically under the chemical name alendronate; Roche Holding AG's (ROG.VX: Quote, Profile, Research, Stock Buzz) Boniva; Novartis AG's (NOVN.VX: Quote, Profile, Research, Stock Buzz) Reclast; and Warner Chilcott Plc's (WCRX.O: Quote, Profile, Research, Stock Buzz) Actonel.
"Although it is not clear if bisphonsphonates are the cause, these unusual femur fractures have been identified in patients taking these drugs," the FDA said. "FDA recommends that healthcare professionals be aware of the possible risk of unusual femur fractures in patients taking bisphosphonates."
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.
Ronald Rogers, a spokesman for Merck, 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.
Terence Hurley, a spokesman for Roche, said no causal link has been established for Boniva and atypical fractures.
Officials at Novartis and Warner Chilcott 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.
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.
Bisphosphonates, which have been on the market for roughly a decade, have raised safety concerns in the past, including heart risks.
A report in the New England Journal of Medicine in 2007 had raised concerns about serious atrial fibrillation, a type of abnormal heart beat. In 2008, the FDA said the drugs showed no overall risk of heart problems.
But it requested information from all bisphosphonate drug makers related to atypical femur fractures. In March, the agency said it was working with the ASBMR to help assess the risk of such fractures.
Now that the report is final, the agency will decide on its next step.
The FDAs statement was made on its website at: here. (Additional reporting by Susan Heavey and Ransdell Pierson; editing by Andre Grenon, Gary Hill)
