FDA Reviews Possible Risk Of Rare Cancer From Bone Drugs

Jul 21, 2011

The Food and Drug Administration is trying to figure out, once and for all, if popular osteoporosis pills can increase the risk of throat cancer.

For now, the agency said the benefits of the medicines in reducing the risk of bone fractures in people with osteoporosis still outweigh the risks. The drugs belong to a group called bisphosphonates and include such brand names as Fosamax, Boniva and Actonel.

The FDA hasn't concluded that people taking the pills have a higher risk for esophageal cancer, but the agency said today that it's looking into the possibility.

Some research has suggested that regular use of the pills could increase that risk. A paper published in BMJ, the British Medical Journal, last year suggested the medicines could double the risk of such cancers. But the cancers are rare, and the doubling would lead to about 2 cases per 1,000 people over five years instead of 1 case per 1,000 people (among people aged 60 to 79).

In a BMJ editorial published to accompany the paper, an FDA epidemiologist wrote that even if the risk for such cancers is low, "the possibility of adverse effects on the esophagus should prompt doctors who prescribe these drugs to consider risks versus benefits...."

But another look at the same database that was published in JAMA, the Journal of the American Medical Association, concluded there was no increased risk for either throat or stomach cancer.

The bisphosphonate pills can irritate the esophagus. And people aren't suppoed to lie down, eat or drink anything for at least half an hour or longer after taking the pills to minimize that sort of trouble.

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