Newspaper article International Herald Tribune

Scrutiny for Bone-Building Drugs ; after U.S. Study, Concern Is Whether Long-Term Use Can Have Opposite Effect

Newspaper article International Herald Tribune

Scrutiny for Bone-Building Drugs ; after U.S. Study, Concern Is Whether Long-Term Use Can Have Opposite Effect

Article excerpt

The U.S. Food and Drug Administration published an analysis that suggested a cautious approach to the long-term use of bone-building drugs but offered little specific guidance.

In an unusual move that may prompt millions of women to rethink their use of popular bone-building drugs, the U.S. Food and Drug Administration has published an analysis that suggested caution about long-term use of the medicine but fell short of issuing specific recommendations.

The F.D.A. review, published in The New England Journal of Medicine online Wednesday, was prompted by a growing debate about how long women should continue using the drugs, known as bisphosphonates, which are sold as generic versions of brands like Fosamax and Boniva, as well as Novartis's Reclast. The concern is that after years of use, the drugs may in rare cases actually lead to weaker bones in certain women, contributing to "rare but serious adverse events," including unusual femur fractures, esophageal cancer and osteonecrosis of the jaw, a painful and disfiguring crumbling of the jaw bone.

Although the concerns about the long-term safety of bone drugs are not new, the F.D.A. performed its own systematic review of the effectiveness of bisphosphonates after years of use. The agency's analysis, which found little if any benefit from the drugs after three to five years of use, may prompt doctors to rethink how they prescribe them.

The F.D.A. review analyzes only long-term use and does not address whether a woman should be prescribed a bone drug in the first place to reduce her fracture risk. Because serious complications are so rare, most doctors believe that for women with documented osteoporosis who are at very high risk for spinal fractures, the benefits of the drugs far outweigh the risks. However, some women with moderate bone density and no other risk factors continue to take the drugs for years even though they are unlikely to gain any benefits.

"I think a lot of people are going to come off this drug," said Dr. Clifford J. Rosen, an endocrinologist and researcher at the Maine Medical Center Research Institute in Portland, Maine.

Bones are in a constant state of remodeling but after age 30 or so, a woman's bones start to dissolve faster than they can be rebuilt, and after menopause she may develop thin, brittle bones that are easily broken. Bisphosphonates slow this process. The drugs are incorporated into newly formed bone and can persist there for years, long after a patient stops taking them.

The F.D.A. report offered little specific guidance about long- term use, saying that the decision to continue or stop treatment should be based on an individual assessment of risks, benefits and preferences discussed between a patient and her doctor. The agency did say that women at low risk for fracture or with a bone density near normal may be good candidates to stop therapy after three to five years, but older patients at higher fracture risk and bone density "in the osteoporotic range" may benefit from continued therapy.

But an accompanying article by Dr. Rosen and others, also published in The New England Journal of Medicine, offers more specifics, concluding that the women most likely to benefit from long-term use of the drugs are those who, after three to five years of treatment, continue to have very low bone density, as measured by a "T score" that is lower than minus 2. …

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