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FDA: No Clear Connection Between Bisphosphonates and Femur Fractures

by Astrid Fiano, DOTmed News Writer | March 15, 2010
A closely watched
drug treatment controversy
In the course of an ongoing safety review, the Food and Drug Administration (FDA) has announced that as of yet, data under review has not indicated that there is a clear connection between the use of bisphosphonates and a risk of atypical subtrochanteric femur fractures. The common brand names of oral bisphosphonates include Fosamax, Actonel, Boniva, and Reclast. The FDA notes that news reports have raised issues about an increased risk of atypical subtrochanteric femur fracture in patients with osteoporosis using these medications. The FDA is continuing to work with outside experts, including members of the American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to collect, review and evaluate information on the issue.

The FDA is recommending that health care professionals follow the guidelines on the drug label when prescribing oral bisphosphonates, and discuss with patients the known benefits and potential risks of using oral bisphosphonates. Patients should continue use of oral bisphosphonates unless their health care provider advises them to discontinue. If patients develop hip or thigh pain or have concerns about their medication, they should discuss this with their health care provider. Patients and health care professionals can also report any side effects with bisphosphonate medications to FDA's MedWatch on the FDA website.

The FDA recommendations can be accessed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm204127.htm