FDA Still Cautious About Bone Drugs


The drugs are incorporated into the newly formed bone and can stay there for years, even after a woman stops taking them.

It's not clear how many women are affected by the FDA's recommendations, but the researchers estimated that as many as 70 percent of women currently taking bisphosphonates could be candidates for stopping the drugs after five years. A number of women stop taking the drugs after only one or two years anyway, because of several inconvenient aspects of the prescriptions, such as needing to remain upright for several hours after taking the drug.

Doctors emphasize that the risk of atypical fractures associated with bisphosphonates is very low and appears to account for less than 1 percent of leg and hip fractures overall. Dr. Beatrice Edwards, an associate professor of orthopedic surgery at the Northwestern University Feinberg School of Medicine, said she thinks the drugs are generally safe for as long as five years, but still keeps a close eye on her patients who take them.

"We usually have a discussion about the benefits and risks and look at their bone density," Edwards said. "We may give them a five-year treatment, and then take them off for one or two years."

The FDA's report said additional research is needed before doctors can determine if interruption of treatments is helpful.

For now, the FDA and other experts say women should be mindful of how long they have been taking the drugs and talk to their doctors about whether continuing to use the drugs is best for them. The FDA already placed a statement on the drugs' labels saying patients should be reevaluated periodically.

For patients at low risk of osteoporosis, experts recommend regular exercise and diets rich in calcium and vitamin D for staving off the disease.

ABC News' Dr. C. Michael Minder contributed to this report.

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