FDA voices OK for Lyrica

            ` ROCKVILLE , MD - The U.S. Food and Drug Administration approved Lyrica, the first drug to treat fibromyalgia, a disorder characterized by pain, fatigue, and sleep problems. Lyrica cuts pain and improves daily functions for some patients with fibromyalgia. Two double-blind, controlled clinical trials, involving about 1,800 patients, support approval for treatment with doses of 300mg or 450mg per day. The most common side effects of Lyrica include mild-to-moderate dizziness and sleepiness. Blurred vision, weight gain, dry mouth, and swelling of the hands and feet were reported in clinical trials. The side effects appeared to be dose-related. Lyrica can impair motor function and cause problems with concentration and attention. FDA advises patients talk to their doctor or other healthcare professional about whether use of Lyrica may impair their ability to drive. Lyrica already is approved for treating partial seizures, pain following the rash of shingles and pain tied to nerve damage (diabetic neuropathy). Lyrica is made by Pfizer Inc., which agreed to perform a study of the drug in children with fibromyalgia and a study in breast-feeding women. To see the press release, visit www.fda.gov/bbs/topics/NEWS/2007/NEW01656.html.