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FDA warns of possible femoral fractures with bisphosphonates
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The FDA today released a statement warning health care professionals and patients about the possible risk for atypical femoral fractures in patients who take bisphosphonates.
Although it is not clear whether bisphosphonates are the direct cause, atypical femoral fractures have been predominantly reported in patients taking bisphosphonates, according to the FDA warning. The optimal duration of bisphosphonate use for osteoporosis is unknown, and the agency is highlighting this uncertainty because atypical femoral fractures may be related to use of bisphosphonates for longer than 5 years.
A labeling change and Medication Guide for bisphosphonates will be incorporated to add warning about the possible risks of long-term use of these drugs, the FDA noted. These changes will affect only bisphosphonates approved for osteoporosis, including oral bisphosphonates such as alendronate (Fosamax, Fosamax Plus D; Merck), risedronate (Actonel, Actonel Plus Calcium; Proctor & Gamble), ibandronate (Boniva, Roche), and their generic products, as well as injectable bisphosphonates such as Reclast and Boniva. The changes will not apply to bisphosphonates used for Paget’s disease or cancer/hypercalcemia, such as etidronate (Didronel, Proctor & Gamble), tiludronate (Skelid, Sanofi Aventis), zoledronic acid (Reclast, Zometa; Novartis), and their generic products.
“The FDA is continuing to evaluate data about the safety and effectiveness of bisphosphonates when used long-term for osteoporosis treatment,” Sandra Kweder, MD, deputy director, Office of New Drugs in the FDA Center for Drug Evaluation and Research, stated in a FDA press release. “In the interim, it’s important for patients and health care professionals to have all the safety information available when determining the best course of treatment for osteoporosis.”
Ongoing safety review
The warning follows a March 2010 FDA Drug Safety Communication announcing the agency’s ongoing safety review of bisphosphonate use and the occurrence of atypical femur fractures. The FDA has since reviewed all available data on bisphosphonate use, including data summarized in the American Society for Bone Mineral Research Task Force report. The report recommended additional product labeling, better identification and tracking of patients experiencing these breaks, and more research to determine whether and how these drugs cause the serious but uncommon fractures, according to the FDA statement.
In the interim
The FDA recommends that health care professionals be aware of the possible risk in patients taking bisphosphonates and consider periodic re-evaluation of the need for continued bisphosphonate therapy for patients who have been on bisphosphonates for longer than 5 years.
Patients taking bisphosphonates for osteoporosis should not stop using their medication unless advised 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. Patients and health care professionals are encouraged to report adverse events associated with the use of bisphosphonates to the FDA’s MedWatch Adverse Event Reporting program.