Safety Alerts & Recalls

What does this mean?

Atypical fractures of the thigh are uncommon and appear to account for less than 1% of all hip and thigh fractures overall. Bisphosphonate medicines continue to be effective in reducing the risk of the more common bone fractures in individuals with osteoporosis. If you have any concerns about your medicine, please discuss them with your healthcare professional.

If you are currently taking alendronate (Fosamax, Fosamax Plus D), ibandronate (Boniva), risedronate (Actonel, Actonel with Calcium, Atelvia), or zoledronic acid (Reclast) for osteoporosis, the FDA advises that you:

1) Keep taking your medicine unless you are told to stop by your healthcare professional.

2) Read the Medication Guide provided with your prescription of bisphosphonate medicine. It will describe the symptoms of an atypical femur fracture of the thigh.

3) Tell your health care professional if you develop new hip or thigh pain (commonly described as dull or aching pain) so that you may be evaluated to rule out an atypical fracture of the thigh.

4) Patients and healthcare professionals should report any side effects with the use of bisphosphonates to FDA's MedWatch program by phone at 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 Updates Prescribing Information to Warn of Possible Fracture Risk With Osteoporosis Drugs

The U.S. Food and Drug Administration (FDA) today warned patients and healthcare providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis. A labeling change and Medication Guide will reflect the risk of these uncommon fractures. Today's warning follows a March 10, 2010, Drug Safety Communication announcing the FDA's ongoing safety review of bisphosphonate use and the occurrence of atypical fractures of the thigh. The FDA has since reviewed all available data on bisphosphonate use, including data summarized in the American Society for Bone Mineral Research Task Force report that was released in September 2010. iGuard previously published safety alerts about the FDA's statements on this issue in March and September 2010.

Bisphosphonates approved to prevent and treat osteoporosis include oral bisphosphonates such as alendronate (Fosamax, Fosamax Plus D), ibandronate (Boniva), risedronate (Actonel, Actonel with Calcium, Atelvia), as well as injectable bisphosphonates such as zoledronic acid (Reclast) and ibandronate (Boniva). Labeling changes and the Medication Guide will not apply to bisphosphonates used for Paget's disease or cancer/hypercalcemia such as Didronel, Zometa, Skelid and their generic products.

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Source: FDA
Publication Date: 2010-10-13
Last Updated: 2010-10-14
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