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Characterized by muscle pain, stiffness, and fatigue, fibromyalgia is a mysterious and debilitating disorder with no known cause. Although pregabalin (Lyrica) and other drugs have been used off-label to treat fibromyalgia, pregabalin is the first to receive FDA approval for this indication. It was previously approved to treat diabetic peripheral neuropathy and postherpetic neuralgia, and as adjunctive therapy for adults with partial-onset seizures.


To support its decision, the FDA cited two double-blind, controlled studies involving about 1,800 people. Results support using pregabalin in doses of 300 mg or 450 mg per day. Adverse reactions to the drug include dizziness, sleepiness, blurred vision, weight gain, dry mouth, and edema of hands and feet. For more information, visit the FDA's Web site at http://www.fda.gov/consumer/updates/fibromyalgia062107.html.