Recent news reports have raised questions regarding a possible association between oral bisphosphonates and atypical fractures in the bone just below the hip joint. Oral bisphosphonates are commonly prescribed to prevent or treat osteoporosis in postmenopausal women. Common brand names of medications in this class include Fosamax®, Actonel®, Boniva®, and Reclast®.

To formally address the issue, the Food and Drug Administration (FDA) is conducting its own review and is working closely with outside experts to review the available data. To date, the data reviewed have not revealed a clear connection between bisphosphonate use and a risk of these atypical fractures.

Until further notice, the FDA is advising the following:

For patients who currently take an oral bisphosphonate:

• 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 medications.
• Report any side effects with bisphosphonate medication to FDA’s MedWatch program.

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 FDA’s MedWatch program using the information at the bottom of the page in the “Contact Us” box.

This communication is in keeping with the 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.

1. Food and Drug Administration (FDA) [website]. Drugs. FDA Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures. March 10, 2010. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203891.htm. Accessed March 11, 2010.

Posted in News Service
This entry was posted on Thursday, March 11th, 2010 at 12:00 pm.