Stronger Caution Lables Recommended for Bone-Building Drugs

The U.S. Food and Drug Administration recently convened two advisory panels in order to conduct a broad safety review of bone-building drugs, which are currently being used by approximately five million women in the United States alone. The two groups ultimately concluded that stronger cautionary language should be added to these bone-building drugs, which include popular brands like Fosamax, Actonel and Boniva.

However, while the two panels did back the need for updated warnings on the drugs, they did not go so far as to specify the exact language the medication’s labels should carry. Regardless, the FDA is expected to release an updated label for these medications sometime in November.

The FDA’s need for the advisory panels was prompted by its recepit of reports that a small group of long-term users had suffered unusual bone fractures or a severe jaw disease. Ultimately, the meetings resulted in a 17-6 vote in favor of a solitary question: Should the labels for bisphosphonates “further clarify the duration of use” of the drugs? Despite the fact the panels’ members did not make a final recommendation regarding length of use, they did suggest that the current labels are too vague and need to be updated to reflect the serious risks associated with long-term use of the drugs. The advisory panel also suggested that the FDA study the overall effectiveness of the drugs, as well as take a closer look at why they are prescribed as preventative medication for women who have not yet developed osteoporosis.

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