1st U.S. Drug Approved for Fibromyalgia

Millions have the painful condition

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THURSDAY, June 21, 2007 (HealthDay News) -- Lyrica (pregabalin) has been approved by the U.S. Food and Drug Administration to treat fibromyalgia. It's the first drug approved in the United States to treat the condition that affects up to 6 million Americans, the agency said Thursday.

People with fibromyalgia usually have chronic pain, muscle stiffness, fatigue, and sleep problems. The disorder affects more women than men, and commonly develops in early-to-middle adulthood. In the absence of a diagnostic test, doctors typically conduct physical examinations, evaluate symptoms, and rule out other possibilities, the FDA said.

Lyrica was approved for fibromyalgia following clinical trials involving about 1,800 people, although not all participants were helped by the drug, the agency said. Common side effects of the medication included dizziness, sleepiness, blurred vision, weight gain, dry mouth, and swelling of the extremities. Lyrica also can impair motor function and cause problems with concentration and attention, the FDA said.

The agency warned prospective users to discuss with their doctor whether Lyrica could impair the ability to drive.

Lyrica, manufactured by Pfizer, Inc., is already approved to treat partial seizures, and pain from shingles and diabetic neuropathy.

More information

The FDA has more about this medication.

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