Safety Alerts & Recalls

What does this mean?

At this time, the FDA has not found a clear connection between the use of oral bisphosphonate medications and fractures of the femur. The agency will continue to review new information as it becomes available and will update the public once the agency's review is complete. If you have any concerns about your medications, you should talk to your healthcare professional.

If you currently take Alendronate (Fosamax, Fosamax Plus D), Ibandronate (Boniva), Risedronate (Actonel, Actonel W/Calcium), or Zoledronic acid (Reclast) you should:

- Continue taking your medication. Do not stop taking your medication unless told to do so by your healthcare professional.

- Talk to your healthcare professional if you develop new hip or thigh pain or have any concerns with your medication.

- Report any side effects with your bisphosphonate medication to FDA's MedWatch program by phone 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA Publishes Results of Ongoing Safety Review of Oral Bisphosphonates and Femur Fractures

Patients and healthcare professionals may have questions about oral bisphosphonate medications and fractures, specifically atypical subtrochanteric femur fractures which is a fracture in the bone just below the hip joint. Oral bisphosphonates are commonly prescribed to prevent or treat osteoporosis. Medications in this class include Alendronate (Fosamax, Fosamax Plus D), Ibandronate (Boniva), Risedronate (Actonel, Actonel W/Calcium), and Zoledronic acid (Reclast).

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 the FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. The FDA 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.

For more information, please visit: more information here

Source: FDA
Publication Date: 2010-03-11
Last Updated: 2010-03-13

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