From Our 2007 Archives

FDA OKs Lyrica as 1st Fibromyalgia Drug

Drug Relieves Fibromyalgia Pain for Some Patients

By Miranda Hitti
WebMD Health News

Reviewed by Louise Chang, MD

June 21, 2007 -- The FDA today approved Lyrica as the first drug treatment for fibromyalgia. Lyrica isn't a cure, but it may ease fibromyalgia pain for some patients, according to the FDA.

Fibromyalgia is a chronic disorder of the muscles and related soft tissue, including ligaments and tendons. Its main symptoms are muscle pain, fatigue, sleep disturbances, and tender points at certain points of the body.

Fibromyalgia affects about 3 million to 6 million people in the U.S each year. The disorder mostly affects women and typically develops in early to middle adulthood, according to the FDA.

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

Lyrica is already approved by the FDA for the treatment of nerve pain caused by shingles and by diabetes. The drug also reduces some forms of epileptic seizures.

'Important Advance' for Fibromyalgia Treatment

Lyrica reduces pain and improves daily functions for some patients with fibromyalgia, notes the FDA.

"Today's new approval marks an important advance, and provides a reason for optimism for the many patients who will receive pain relief with Lyrica," says the FDA's Steven Galson, MD, MPH, in an FDA news release.

"However, consumers should understand that some patients did not experience benefit in clinical trials. We still have more progress to make for treatment of this disorder," says Galson, who directs the FDA's Center for Drug Evaluation and Research.

Lyrica's Fibromyalgia Trials

People 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.

The FDA approved Lyrica for the treatment of fibromyalgia based on two clinical trials that included about 1,800 fibromyalgia patients. The trials backed Lyrica's use in treating fibromyalgia at doses of 300 milligrams or 450 milligrams per day, according to the FDA.

Lyrica's Side Effects

In Lyrica's clinical trials for fibromyalgia treatment, the drug's most common side effects included mild to moderate dizziness and sleepiness. Blurred vision, weight gain, dry mouth, and swelling of the hands and feet also were also reported in the clinical trials.

Side effects appeared to correlate with the drug's dose, notes the FDA.

Lyrica can impair motor function and cause problems with concentration and attention. The FDA advises patients to talk to their doctor or other health care professional about whether the use of Lyrica may impair their ability to drive.

Lyrica is made by Pfizer, which has agreed to perform a study of the drug in children with fibromyalgia and a study in breastfeeding women.

Lyrica has been prescribed for 5 million patients worldwide for various uses, according to a Pfizer news release.

SOURCES: WebMD Health News: "Lyrica May Help Ease Fibromyalgia Pain." WebMD Medical News: "Lyrica May Relieve Fibromyalgia Pain." News release, Pfizer.

© 2007 WebMD, Inc. All rights reserved.





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