The labeling for bisphosphonates will be updated to include information in the Warnings and Precautions section about the risk of atypical fractures of the thigh (ie, subtrochanteric and diaphyseal femur fractures) in patients who take bisphosphonates for osteoporosis. Although it is not clear if bisphosphonates are the cause, these unusual femur fractures have been predominantly reported in patients taking bisphosphonates and may be related to long-term term bisphosphonate use. The FDA will require a new Limitations of Use statement in the Indications and Usage section of the labels for these drugs. This statement will describe the uncertainty of the optimal duration of use of bisphosphonates for the treatment and/or prevention of osteoporosis.
Only those bisphosphonates approved to treat osteoporosis are affected and include Actonel (risedronate tablets, from Warner Chilcott), Atelvia (risedronate sodium delayed-release tablets, from Warner Chilcott), 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).
Patients should continue to take their medication unless told to stop by their healthcare provider. The FDA recommends that healthcare professionals should discontinue potent antiresorptive medications (including bisphosphonates) in patients who have evidence of a femoral shaft fracture.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm229244.htm.