Bisphosphonates to get additional labeling

Sept. 10, 2011 at 9:28 PM
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WASHINGTON, Sept. 10 (UPI) -- An advisory panel of the U.S. Food and Drug Administration voted to require osteoporosis drugs to provide additional labeling information, officials say.

Dr. Theresa Kehoe, a scientist at the FDA, told the panel the agency's analysis of women who continue bisphosphonate therapy -- such as Aclasta, Actonel, Altevia, Boniva, Fosamax and Reclast -- after five years show no clear benefit or evidence of harm, WebMD reported.

Earlier research found 4.7 million Americans take oral bisphosphonates -- some women begin taking it in their 50 or 60s to prevent osteoporosis -- but there was a scarcity of long-term studies. The FDA has received complaints concerning osteonecrosis, or bone death, of the jaw and unusual fractures of the femur, or thigh bone, in women who had taken the drugs for several years or more.

One study randomly assigned women who had already taken Fosamax daily for five years to either continue taking the drug for another five years or stop.

For fractures other than those of the spine, there was no evidence overall of continued benefit after five years, said Dr. Douglas Bauer, a University of California, San Francisco, primary care physician invited by the FDA to address the advisory panel.

However, there was a 55 percent reduction in spine fracture risk in women who continued taking Fosamax for the extra five years, Arthur Santora, executive director of clinical research for diabetes and endocrinology drugs at Merck, which makes Fosamax.

Santora said after 10 years, there were no reports of jawbone death and no difference in the risk of unusual thigh fractures between women who took the drug and those who didn't, WebMD says.

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