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FDA Advisers Call for Revised Labels for Osteoporosis Drugs
Date:9/9/2011

By Steven Reinberg
HealthDay Reporter

FRIDAY, Sept. 9 (HealthDay News) -- U.S. Food and Drug Administration advisers recommended Friday that osteoporosis drugs such as Fosamax, Actonel, Boniva and Reclast come with revised labels, clarifying how long a patient should take a drug before potential health risks set in.

The drugs, known as bisphosphonates, are taken to prevent fractures related to postmenopausal osteoporosis. But researchers have linked long-term use with a small risk of unusual fractures of the thigh bone, death of the jawbone (osteonecrosis of the jaw) and possibly esophageal cancer.

By a 17-6 vote, the FDA advisers recommended that the drug labels -- or package inserts -- should be clarified, detailing the best duration of use for each drug. But the advisers did not offer specific wording changes; the label wording could vary for each drug, the Associated Press reported.

The revised labels should "be very clear that efficacy may fall off after a period of time, perhaps five years," panelist Dr. Lewis Nelson, director of the medical toxicology fellowship program at New York University, said after the vote, Bloomberg News reported. "Serious concerns have been raised about risk, and those need to be continually evaluated as well."

The FDA is not compelled to follow the recommendations of its advisory committees but it usually does so.

According to the FDA, in 2009 more than 5 million prescriptions were filled for bisphosphonates, which inhibit bone loss.

Dr. Elizabeth Shane, past president of the American Society for Bone and Mineral Research, who was scheduled to testify before the committee, said reports linking bisphosphonates with atypical fractures and osteonecrosis of the jaw are "extremely rare, when considered in the context of how many people take bisphosphonates for osteoporosis." She was "less certain about the esophageal cancer issue," she added.


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