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Podcast for Healthcare Professionals: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures

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Welcome, my name is Catherine Chew, a pharmacist in the Division of Drug Information. Today I am updating you about an ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures.

Healthcare professionals may have questions about oral bisphosphonate medications and atypical subtrochanteric femur fractures – fractures in the bone just below the hip joint.

Recent news reports have raised the question about whether there is an increased risk of this type of fracture 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, FDA, in June 2008, 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, FDA reviewed a December 2008 article in the Journal of Bone and Mineral Research by Abrahamsen and co-authors that analyzed data from two 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 agency will continue to review new information as it becomes available and is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue.

Once additional information is available, FDA will update the public about this issue.

At this time, FDA recommends that healthcare professionals:

1. Be aware of the possible risk of atypical subtrochanteric femur fractures in patients taking oral bisphosphonates.

2. Continue to follow the recommendations in the drug label when prescribing oral bisphosphonates.

3. Discuss with patients the known benefits and potential risks with using oral bisphosphonates.

4. Report any adverse events with the use of oral bisphosphonates to FDA's MedWatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. If you have questions about this safety communication, you can reach the Division of Drug Information at the following email address: druginfo@fda.hhs.gov.

 

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