Oral Bisphosphonate Users May Be At Risk of Femur Fracture

Cheryl A. Thompson

BETHESDA, MD 10 March 2010—FDA today announced it has not found a "clear connection" between the use of oral bisphosphonates and a risk of atypical fractures in the bone below the hip joint.

The announcement came after two presenters at the annual meeting of the American Academy of Orthopaedic Surgeons were reported to have said their research suggested that bisphosphonates, if used for four or more years, may impair bone quality.

FDA said it is working with outside experts to gather more information about atypical subtrochanteric femur fractures in oral bisphosphonate users. The agency said it has already reviewed all the case reports and clinical trial data provided by the companies marketing alendronate sodium, etidronate disodium, ibandronate sodium, pamidronate disodium, risedronate sodium, tiludronate disodium, and zoledronic acid.

Health care professionals, FDA said, should continue to follow the recommendations in the drugs' labeling when prescribing oral bisphosphonates.

But, the agency added, health care professionals should be aware that patients taking an oral bisphosphonate may be at risk of atypical subtrochanteric femur fractures.