Bisphosphonates to carry warning about femur fractures

The labels of bisphosphonate drugs will now carry a warning describing the risk of subtrochanteric and diaphyseal femur fractures, the FDA announced last week.

Information about the risk of these atypical fractures will be added to the warnings and precautions section of the labels of all bisphosphonate drugs approved for the prevention or treatment of osteoporosis, including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast (and their generic equivalents). The new regulations also require that a medication guide be given to patients when they pick up their bisphosphonate prescription.

The FDA's action was based on data showing that the unusual femur fractures have been predominantly reported in patients taking bisphosphonates. It is not clear if bisphosphonates are the cause of the fractures, which are very uncommon and appear to account for less than 1% of all hip and femur fractures overall, the agency noted.

The FDA recommends that physicians be aware of the possible risk of atypical subtrochanteric and diaphyseal femur fractures in patients taking bisphosphonates and discontinue potent antiresorptive medications (including bisphosphonates) in patients who have evidence of a femoral shaft fracture. Clinicians should also evaluate any patient who presents with new thigh or groin pain to rule out a femoral fracture. Because the risk of fractures may relate to long-term use of bisphosphonates, it's also appropriate to consider periodic reevaluation of the need for continued therapy, particularly in patients who have been treated for over five years.