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  • FDA Date: 03/10/2010

    Fosamax (alendronate sodium) FDA Drug Safety Communication

    Ongoing Safety Review of Oral Bisphosphonates and Atypical Subtrochanteric Femur Fractures

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    Patients and 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. Common brand names in this class include Fosamax (alendronate), Actonel (risedronate), Boniva (ibandronate), and Reclast (zoledronic acid).

    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. FDA is working closely with outside experts to gather additional information that may provide more insight into this issue.

    - Healthcare professionals should continue to follow the recommendations in the drug label when prescribing oral bisphosphonates.

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

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

    This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs. The agency will continue to review new information as it becomes available and will update the public once the agency's review is complete.

    View the full FDA Drug Safety Communication on FDA.gov