Sunday, September 21, 2014
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FDA warns of facture risk from osteoporosis drugs

The Food and Drug Administration announced Wednesday that it would require label changes to bisphosphonates - the class of drugs prescribed to treat osteoporosis in postmenopausal women - to ward of an apparent increased risk of rare thigh fractures from the medications. The FDA noted that the factures of the femur are uncommon, accounting for less than 1 percent of hip and thigh fractures. The federal drug agency stated "Although it is not clear if bisphosphonates are the cause, these unusual femur fractures have been predominantly reported in patients taking" the drugs.

FDA warns of facture risk from osteoporosis drugs

The Food and Drug Administration announced Wednesday that it would require label changes to bisphosphonates – the class of drugs prescribed to treat osteoporosis in postmenopausal women – to warn of an apparent increased risk of rare thigh fractures from the medications.

The FDA noted that the factures of the femur are uncommon, accounting for less than 1 percent of hip and thigh fractures. The federal drug agency stated “Although it is not clear if bisphosphonates are the cause, these unusual femur fractures have been predominantly reported in patients taking” the drugs.

The drugs affected by the change are only those approved by the FDA to treat osteoporosis. These include: Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa and their generic versions.

“Although the optimal duration of bisphosphonate use for osteoporosis is unknown, these atypical fractures may be related to long-term term bisphosphonate use,” the FDA added. “These actions are part of an ongoing safety review of bisphosphonate use.”

The FDA provided the following information for patients now using the medications:

Continue to take your medication unless you are told to stop by your healthcare professional.
Talk to your healthcare professional if you develop new hip or thigh pain (commonly described as dull or aching pain), or have any concerns with your medications.

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Check Up covers major health events in our region and offers everything from personal health advice to an expert look at health reform. Read about some of our bloggers here.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section

Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
Daniel R. Hoffman, Ph.D. President, Pharmaceutical Business Research Associates
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