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Osteoporosis Drugs' Safety Subject of FDA Panel
Date:9/9/2011

By Steven Reinberg
HealthDay Reporter

FRIDAY, Sept. 9 (HealthDay News) -- Experts convened by the U.S. Food and Drug Administration were to meet Friday to discuss problems linked to long-term use of bone-building drugs such as Fosamax, Actonel, Boniva and Reclast.

These 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.

Members of two FDA advisory committees are expected to weigh the drugs' risks and benefits and possibly come up with new recommendations regarding their use. 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 is 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.

While these side effects shouldn't be downplayed, "when you consider the number of very dangerous, life-threatening fractures that are prevented by these drugs, the benefits dwarf the side effects," said Shane, also a professor of medicine at Columbia University in New York City.

However, she said bisphosphonates should only be prescribed to those at the highest risk of fracture. "In the past we might have used them in people who aren't at such high risk of fracture in the hope that they would prevent fractures down the line," she said. "We have moved to targeting people at high short-term risk, which means in the next five to 10 years."

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