The FDA says it is re-investigating the issue of whether drugs like Fosamax, which are given to post-menopausal women, can actually cause fractures of the thigh bone (femur).
A number of lawsuits are pending about death of jaw bone tissue allegedly caused by this family of drugs, called biophosphonates.
Previously the FDA said it had seen no link between these drugs and femur fractures. But new studies reported at the annual meeting of the American Academy of Orthopaedic Surgeons raised questions about the risks for long-term use of bisphosphonates by post-menopausal women.
The FDA says it will consult with outside experts. Meantime, it says people on the medications should continue taking them but should talk to their doctors if get any new hip or thigh pain. See the FDA’s news release here.
Bisphosphonates have combined annual sales topping $3.5 billion. In addition to Fosamax, drugs in the group includes Actonel marketed by Sanofi-Aventis and Procter & Gamble, Boniva marketed by Roche and GlaxoSmithKline, Novartis’s Reclast and P&G’s Actonel.