The FDA has changed the lable for bisphosphonates adding a warning about possible risks of long-term use of osteoporosis drugs. Patients are being warned about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis.
Bisphosphonates inhibit the loss of bone mass in people with osteoporosis. Bisphosphonates have been shown to reduce the rate of osteoporotic fractures — fractures that can result in pain, hospitalization, and surgery– in people with osteoporosis. While it is not clear whether bisphosphonates are the cause, atypical femur fractures, a rare but serious type of thigh bone fracture, have been predominantly reported in patients taking bisphosphonates. The optimal duration of bisphosphonate use for osteoporosis is unknown, and the FDA is highlighting this uncertainty because these fractures may be related to use of bisphosphonates for longer than five years.
The labeling changes and Medication Guide will affect only those bisphosphonates approved for osteoporosis, including oral bisphosphonates such as Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and their generic products, as well as injectable bisphosphonates such as Reclast and Boniva.
Labeling changes and the Medication Guide will not apply to bisphosphonates used for Paget’s disease or cancer/hypercalcemia such as Didronel, Zometa, Skelid, and their generic products.
The FDA recommends that health care professionals be aware of the possible risk in patients taking bisphosphonates and consider periodic reevaluation of the need for continued bisphosphonate therapy for patients who have been on bisphosphonates for longer than five years.
Patients taking bisphosphonates for osteoporosis should not stop using their medication unless told to do so by their health care professional. Those taking bisphosphonates also should report any new thigh or groin pain to their health care provider and be evaluated for a possible femur fracture.
FDA WARNING UPDATE – Bisphosphonates Class Label Change
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Actonel (risedronate sodium) tablets
Actonel with Calcium (risedronate sodium with calcium carbonate tablets)
Atelvia (risedronate sodium) delayed-release tablets
Boniva (ibandronate sodium) tablets
Fosamax (alendronate sodium) tablets and oral solution
Fosamax Plus D (alendronate sodium/cholecalciferol) Tablets
Reclast (zoledronic acid) Injection
5 WARNINGS AND PRECAUTIONS
5.5 Atypical Subtrochanteric and Diaphyseal Femoral Fractures
Atypical, low-energy, or low trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. These fractures can occur anywhere in the femoral shaft from just…..
MEDICATION GUIDE (new)
JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION: Bisphosphonate Use and the Risk of Subtrochanteric or Femoral Shaft Fractures in Older Women – http://jama.ama-assn.org/content/305/8/783