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Thursday, May 10, 2012

FDA’s Stance on Bisphosphonate Drugs

The FDA is weighing in on how long is long enough to take bisphosphonates – a widely used class of osteoporosis drugs that includes Actonel, Atelvia, Boniva, and Fosamax.

The short answer: It depends, but 5 years may be the key time frame. After that, it’s not clear if the benefits may not outweigh potential risks.

But the FDA isn’t saying that anyone should stop taking bisphosphonates. It’s not known who should still keep taking the drugs and who might be better off stopping them.

The FDA has been studying bisphosphonates’ safety for some time. Its FDA advisory panel weighed in last September, calling for improved labeling of the drugs.

This week in The New England Journal of Medicine, the FDA points out that all bisphosphonates have an “Important Limitation of Use” statement that reads: “The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.” More studies are “crucial,” the FDA writes.

In the meantime, what to do if you’re taking bisphosphonates? Make that decision with your doctor, based on your particular risks, benefits, and preferences, the FDA advises.

Posted by: WebMD Blogs at 4:51 pm

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