Bone drugs may cause fractures, FDA warns
Federal health officials are warning that patients taking drugs designed to prevent broken bones may, paradoxically, be at increased risk for certain unusual fractures of the thigh bone.
The Food and Drug Administration issued the warning Wednesday to patients taking drugs known as biophosphonates, which are widely used to treat the bone-thinning disease osteoporosis.
The FDA is requiring that durg companies add a warning to the labels of Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, Reclast and Boniva.
"While it is not clear whether bisphosphonates are the cause, atypical femur fractures, a rare but serious type of thigh bone fracture, have been predominantly reported in patients taking bisphosphonates," particularly those taking the drugs for more than five years, the FDA said in a statement.
The agency is evaluating the safety and effectiveness of bisphosphonates for long-term osteoporosis treatment, said Sandra Kweder, deputy director FDA's office of new drugs in the center for drug evaluation and research. "In the interim, it's important for patients and health-care professionals to have all the safety information available when determining the best course of treatment for osteoporosis."
The FDA stressed that patients taking bisphosphonates for osteoporosis should not stop using their medication unless their doctor tells them to. But they should report any new thigh or groin pain to their doctor so they can be evaluated for a possible thigh fracture, the agency said.
| October 13, 2010; 1:30 PM ET
Categories: Aging, FDA, Women's Health, drug safety
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