FDA backs new labels for osteoporosis drugs

September 10, 2011|Associated Press

TRENTON, N.J. - Food and Drug Administration advisers voted yesterday to require makers of widely used osteoporosis drugs to clarify how long patients should take them for the greatest benefit and least risk.

The FDA will later decide what the new label wording should say for each of the drugs: Fosamax, Boniva, Actonel, Atelvia, and Reclast. The agency could require wording that recommends limiting how long each drug is taken, but those limits are unclear.

A few patients have suffered serious complications, including jawbone destruction, unusual thighbone fractures, and cancer of the esophagus, generally after several years of taking the medicines.

The drugs stop and reverse dangerous thinning of bones in many people. But after several years, it is unclear whether the drugs, a class called bisphosphonates, do more harm than good.

More than 10 million Americans, mostly women older than 50, have osteoporosis, and 34 million more have low bone mass that could lead to osteoporosis, in which the body breaks down bone tissue faster than it rebuilds it.

Some patients suffering jaw damage and hip fractures have sued the drugs’ makers, and law firms aggressively advertise for plaintiffs.

Publicity about the complications and the lawsuits has alarmed many patients.

Specialists have been reviewing data to try to provide better advice on whether patients should stop the drugs totally, or perhaps temporarily, after several years.