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Fracture Worries Prompt FDA to Look at Fosamax, Other Osteoporosis Drugs

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The Food & Drug Administration (FDA) is taking another look at oral bisphosphonate medications, a class of drugs that includes Fosamax, Actonel, Boniva, and Reclast. There continues to be concern that the drugs, used to prevent osteoporosis in post-menopausal women, are associated with a specific type of femur fracture.

According to a notice posted on the FDA’s Web site, in June 2008 the agency requested information from all bisphosphonate drug manufacturers regarding the potential for atypical femur fractures. According to the FDA, a review of available data did not show an increase in this risk in women using these medications.

The latest FDA review was prompted by media reports linking Fosamax and the other drugs to atypical subtrochanteric femur fractures in some patients who’ve been on the drugs for several years. Such fractures occur in the bone just below the hip joint and can be extremely painful.

In announcing this safety review, the FDA said it would work 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.

The FDA has advised that healthcare professionals continue to follow the recommendations in the drug label when prescribing oral bisphosphonates. Patients should not stop taking their medication unless told to do so by their healthcare professional. Patients should talk to their healthcare professional about any concerns they have with these medications, the agency said.

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