Panel asks for label changes for osteoporosis medications

By: Sandra Hughes, CBS News
By: Sandra Hughes, CBS News

Osteoporosis is a dangerous disease that affects millions of women. Medication to treat the disease has helped slow the thinning of bones. But now the Food and Drug Administration is reviewing how long a patient should take the drugs.

Nina Barnett took osteoporosis drugs for almost ten years, then she took a tumble at work.

"I heard my right leg crack and I turned around, turned out totally fractured and left leg was stress fractured," she said.

The electrician had been diagnosed with pre-osteoporosis and took drugs called bis-fos-fo-nates to prevent bone deterioration.

More than four million women in the U.S. take these drugs to maintain strong bones, but the studies on the drug's safety were only for short term use.

"The difficulty is that physicians have been treated these patients indefinitely with these drugs with with very little evidence that they remain safe," said Dr. Joseph Lane, who works for Hospital for Special Surgery.

The drugs have also been linked to jawbone deterioration and unusual leg fractures.

So an FDA panel has recommended the agency require drug makers to label the products with an advisory that the drug should only be taken while it is beneficial.

"If the bone density is stable and test show the bone has gone to sleep, then we take them off the drug until the bones start deteriorating again," said Dr. Lane.

Makers of the drugs warn that women who stop using them could actually suffer more fractures.

Nina Barnett wishes she knew the risks before her accident.

"It turned out terrible damage. It was like toothpicks. My surgeon said he had to put in everything but the kitchen sink to rebuild it," she said.

Now she just wants to be able to walk without crutches.

The Food and Drug Administration doesn't have to follow the advice of the panel, but usually does.


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