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FDA Panel Recommends Changes to Fosamax Side Effects Label

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Washington, DCAn advisory panel for the US Food and Drug Administration (FDA) has recommended changes to warning labels concerning Fosamax side effects. The panel was convened in light of concerns about the link between Fosamax and femur fractures, and a concern about Fosamax osteonecrosis. Despite the recommendations, however, the panel did not recommend patients take a break from Fosamax and other drugs in the bisphosphonate class.

According to USA Today (09/12/11), the FDA panel recommended that the warning labels for bisphosphonate medications—a class that includes Fosamax and Actonel—be revised to indicate how long a patient can take the medication before facing health risks. The panel did not, however, offer recommendations for how the label should be specifically changed or what wording should be used.

Furthermore, the panel did not vote to recommend patients take a drug holiday—a period of time when they do not use the drug—to avoid suffering serious side effects. In convening the panel, the FDA noted that studies show the benefits of bisphosphonate medications for some patients drop off after around five years of use.

Some doctors recommend prescribing the medications on an individual basis, rather than having general guidelines for all patients. This is because some higher-risk patients may still have benefits from the drugs after five years, where lower-risk patients may not need the medications beyond three to five years. Others say the medications should only be used for patients who have the highest risk of bone fracture.

Bisphosphonates are prescribed to prevent hip, spine, wrist and arm fractures in patients with postmenopausal osteoporosis. Some studies, however, have linked the medications to rare thighbone fractures, jawbone death (osteonecrosis of the jaw) and esophageal cancer. According to CBS News (09/12/11), some women who testified before the advisory panel said they were prescribed bisphosphonate medications for osteopenia—a condition in which bone mineral density is low but is not severe enough to be osteoporosis.

Meanwhile, one researcher noted that when bisphosphonates were first approved, they were prescribed to women in their 70s and 80s. Since that time, the medications have been prescribed to women in their 50s and 60s, effectively increasing the amount of time patients can be on the drugs.

The advisory panel can only make recommendations to the FDA; the FDA is not obligated to follow the recommendations, although it usually does. The panel voted 17 to 6 in favor of recommending updated labeling information for bisphosphonates, to clarify for patients how long they should take the medications to achieve the greatest benefits at the least risk. Now the FDA is left to decide if it will follow the panel's recommendations or take other action.


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