Fracture Risk with Osteoporosis Drugs: Fosamax, Actonel, Boniva, Atelvia, Reclast

Osteoporosis / March 1, 2011

Fracture Risk with Osteoporosis Drugs

FDA has issued updated information on atypical fractures of the femur associated with the use of bisphosphonates to treat osteoporosis. These drugs include Fosamax (alendronate sodium), Actonel (risedronate sodium), Boniva (ibandronate sodium), Atelvia (risedronate sodium), Reclast (zoledronic acid), and their generic equivalents.

Video Summary

The FDA has issued updated information on atypical fractures of the femur associated with the use of bisphosphonates to treat osteoporosis. These drugs include Fosamax, Actonel, Boniva, Atelvia, Reclast, and their generic equivalents.

The femur fractures seen with bisphosphonates have been subtrochanteric and diaphyseal, which are uncommon, accounting for less than one percent of the hip and femur fractures that occur in the population overall. Although it’s not clear that the drugs are a direct cause of these unusual fractures, they’ve mainly been reported in patients taking bisphosphonates.

FDA recommends that healthcare professionals be aware of the possibility of atypical femur fractures in patients taking bisphosphonates, that they rule out a femoral fracture if the patient presents with new thigh or groin pain, and that they discontinue potent antiresorptive medications, including bisphosphonates in patients who have evidence of a femoral fracture.

They should also consider periodically reevaluating whether continued bisphosphonate therapy is needed, especially in patients who’ve been treated for more than five years. That’s because the fracture reduction efficacy of these drugs hasn’t been established, and the optimal duration of use is uncertain.

Healthcare professionals should discuss the benefits and risks of these drugs with their patients and instruct them to seek medical attention if they experience new groin or thigh pain which may be described as dull or aching. This pain can occur weeks or months before a complete fracture occurs.

This safety information will appear in the drug’s labeling as well as in a medication guide that will be distributed to patients with each prescription.



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