FDA Links Biphosphonates and Femur Fractures

By Rheingold Giuffra Ruffo & Plotkin LLP

The FDA updated the Warnings and Precautions section of biphosphonates (Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast along with their generics which is Alendronate Sodium) to include a warning regarding atypical femur fractures, specifically subtrochanteric and diaphyseal femur fractures. View the FDA Safety Annoucement here.

The FDA analysis describes an atypical femur fracture as, “occuring anywhere in the femoral shaft, from just below the lower trochanter to above the supracondylar flare, and are transverse or short oblique in orientation without evidence of communition.”

It appears the FDA’s primary guidance came from a report issued by the American Society for Bone and Mineral Research which concluded that although atypical femur fractures are rare, the vast majority of people that have had them had taken biphosphonates.

If you have taken Fosamax, or any other biphosphonate and then fractured your femur contact the experienced attorneys at Rheingold, Giuffra, Ruffo & Plotkin LLP to speak with an attorney that has been handling Fosamax cases for years.

Related Posts