FDA Reassures on Osteoporosis Drugs

Bisphosphonate drugs for osteoporosis do not seem to increase the risk of femoral fractures, the FDA announced, though the bureau will continue to evaluate that possibility.

Case reports had suggested that “atypical” subtrochanteric femur fractures were occurring at higher-than-expected rates in women taking bisphosphonate drugs for osteoporosis.

In 2008, the FDA had requested information from all bisphosphonate drug manufacturers regarding this potential safety signal, the bureau said. The drugs are commonly sold under trade names that include Fosamax, Boniva, Actonel, and Zometa.

“At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures,” the bureau announced Wednesday.

“FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research (ASBMR) Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue.”

The bureau noted that some research has already indicated that these fractures may simply be an outcome of osteoporosis.

It pointed to a 2008 report in the Journal of Bone and Mineral Research examining data from two massive observational studies of osteoporosis patients. Despite the “atypical” label applied to the fractures, the analysis suggested that they resembled those typically seen in patients’ hips, according to the FDA.

Another report presented at the ASBMR’s 2008 annual meeting cleared alendronate (Fosamax) of responsibility for increased “atypical” femoral fractures.

The FDA recommended that health-care providers continue to follow label recommendations for prescribing bisphosphonates. It also urged patients not to stop taking these medications without first speaking to their doctors.

source : www.medpagetoday.com

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Submited at Thursday, March 11th, 2010 at 6:00 am on Geriatric by Alina
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