March 11, 2010
FDA reviews atypical subtrochanteric femur fractures risk with oral bisphosphonatesThe FDA has notified healthcare professionals and patients that at this point, the data that have been reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. The FDA will continue to review new information as it becomes available and will provide an update review is complete.
Healthcare professionals should continue to follow the recommendations in the drug label when prescribing oral bisphosphonates. Patients should not stop taking their medication unless told to do so by their healthcare provider. Patients should talk to their healthcare provider about any concerns they have with these medications.
Oral bisphosphonates are commonly prescribed to prevent or treat osteoporosis in postmenopausal women. Medications in this class include Actonel (risedronate tablets, from Procter & Gamble), Boniva (ibandronate tablets and injection, from Roche), Fosamax (alendronate tablets and oral solution, from Merck), and Reclast (zoledronic acid soln for IV infusion, from Novartis).
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204127.htm.