FDA seeks to establish link between thigh-bone fractures, bisphosphonates

ROCKVILLE, Md. Analysis by the Food and Drug Administration has yet to establish a link between thigh-bone fractures and use of a class of drugs for treating osteoporosis, the FDA said Thursday.

The agency said it was working with outside experts to investigate alleged links between fractures and use of orally administered bisphosphonates, a class that includes Merck & Co.’s Fosamax (alendronate sodium), GlaxoSmithKline’s and Genentech’s Boniva (ibandronate sodium) and Novartis’s Reclast (zoledronic acid).

The investigation follows news reports about studies linking long-term use of the drugs to fractures in post-menopausal women.