FDA Says Bisphosphonates Might Increase Femoral Fracture Risk, Orders Label Change

FDA Says Bisphosphonates Might Increase Femoral Fracture Risk, Orders Label Change

In contrast with earlier reassurance that there was no "clear connection" between use of bisphosphonates and atypical femoral fractures, the FDA now says labeling changes are needed.

Changes to the warnings section of all bisphosphonates given for osteoporosis will highlight the potential risk for subtrochanteric and diaphyseal femoral fractures. In addition, manufacturers will need to include a medication guide for use by patients.

The FDA says that the fractures being reported "may be related to use of bisphosphonates for longer than five years." Consequently, physicians are being asked to reevaluate the need for the drugs if their patients have been using them longer than that.

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