The Food and Drug Administration announced Wednesday that it would require label changes to bisphosphonates – the class of drugs prescribed to treat osteoporosis in postmenopausal women – to warn of an apparent increased risk of rare thigh fractures from the medications.
The FDA noted that the factures of the femur are uncommon, accounting for less than 1 percent of hip and thigh fractures. The federal drug agency stated “Although it is not clear if bisphosphonates are the cause, these unusual femur fractures have been predominantly reported in patients taking” the drugs.
The drugs affected by the change are only those approved by the FDA to treat osteoporosis. These include: Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa and their generic versions.
“Although the optimal duration of bisphosphonate use for osteoporosis is unknown, these atypical fractures may be related to long-term term bisphosphonate use,” the FDA added. “These actions are part of an ongoing safety review of bisphosphonate use.”