Federal health experts said Friday the risks of a sleep drug from Jazz Pharmaceuticals outweigh its benefits for treating the chronic pain disorder fibroymalgia.
The Food and Drug Administration's panel of outside advisers voted 20-2 against recommending approval of the company's application to market sodium oxybate for fibromyalgia, according to an agency spokeswoman. Fibromyalgia is a little-understood condition characterized by muscle pain and fatigue.
The FDA gives weight to the panel's recommendations, but is not required to follow them. The agency is scheduled to make its final ruling on the drug by Oct. 11.
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