The FDA ( Food and Drug Administration ) has approved Lyrica ( Pregabalin ), the first drug to treat fibromyalgia, a disorder characterized by pain, fatigue and sleep problems.

Lyrica reduces pain and improves daily functions for some patients with fibromyalgia.

Persons with fibromyalgia typically experience long-lasting or chronic pain, as well as muscle stiffness and tenderness.
Fibromyalgia affects about 3 million to 6 million people in the United States each year.
The disorder mostly affects women and typically develops in early-to-middle adulthood.

There is no test for the diagnosis of fibromyalgia. Doctors make a diagnosis by conducting physical examinations, evaluating symptoms, and ruling out other conditions.

Individuals with fibromyalgia have been shown to experience pain differently from other people. Studies have shown that such patients have decreased pain after taking Lyrica, but, the mechanism by which Lyrica produces such an effect is unknown.

Two double-blind, controlled clinical trials, involving about 1,800 patients, support approval for use in treating fibromyalgia with doses of 300 milligrams or 450 milligrams 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 also 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.

Lyrica already is approved for treating partial seizures, pain following the rash of shingles and pain associated with diabetes nerve damage ( diabetic neuropathy ).

Source: FDA, 2007


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