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FDA: No Connection Between Oral Bisphosphonates, Atypical Subtrochanteric Femur Fractures ROCKVILLE, Md -- March 12, 2010 -- The US Food and Drug Administration is notifying healthcare professionals and patients that at this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. The FDA is working with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather more information and evaluate the issue further. The FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing oral bisphosphonates such as alendronate (Fosamax), risedronate sodium (Actonel), ibandronate sodium (Boniva), and zoledronic acid (Reclast). Patients should continue taking oral bisphosphonates unless told by their healthcare professional to stop. Patients should talk to their healthcare professional if they develop new hip or thigh pain or have any concerns with their medications. Recent news reports have raised the question about whether there is an increased risk of this type of atypical subtrochanteric femur fractures in patients with osteoporosis using these medications. At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. Based on published case reports of atypical subtrochanteric femur fractures occurring in women with osteoporosis using bisphosphonates, in June 2008, the FDA requested information from all bisphosphonate drug manufacturers regarding this potential safety signal. All available case reports and clinical trial data were requested. FDA’s review of these data did not show an increase in this risk in women using these medications. In addition, the FDA reviewed a December 2008 article in the Journal of Bone and Mineral Research (Abrahamsen et al) that analysed data from 2 large observational studies in patients with osteoporosis. The authors concluded that atypical subtrochanteric femur fractures had many similar features in common with classical osteoporotic hip fractures, including patient age, gender, and trauma mechanism. The data showed that patients taking bisphosphonates and those not taking bisphosphonates had similar numbers of atypical subtrochanteric femur fractures relative to classical osteoporotic hip fractures. The FDA will continue to review new information as it becomes available and will update the public once the agency’s review is complete. Additional Information for Healthcare Professionals · Be aware of the possible risk of atypical subtrochanteric femur fractures in patients taking oral bisphosphonates. · Continue to follow the recommendations in the drug label when prescribing oral bisphosphonates. · Discuss with patients the known benefits and potential risks with using oral bisphosphonates. · Report any adverse events with the use of oral bisphosphonates to the FDA’s MedWatch program using the information at the bottom of this page. To report a serious problem to the FDA: 1-800-332-1088 - Phone 1-800-FDA-0178 - Fax MedWatch 5600 Fishers Lane Rockville, MD 20852-9787 SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version