Green light for first drug to treat fibromyalgia

Jun 25 2007

Authorities in the United States have given approval for the first drug to treat the condition fibromyalgia.

The Food and Drug Administration (FDA) have given drug company Pfizer approval for it's drug Lyrica (pregabalin), to be used to treat the disorder.

Fibromyalgia can cause chronic pain, fatigue, muscle stiffness and tenderness along with sleep problems, but is not progressive or life-threatening.

The condition affects about 3 million to 6 million people in the United States each year, mostly women, and usually develops in early-to-middle adulthood; patients have been found to experience pain differently from others.

There is currently no definitive test for the diagnosis of fibromyalgia and doctors as a rule arrive at a diagnosis by carrying out physical examinations, evaluating symptoms, and eliminating other possible conditions and diseases.

Lyrica has been found to reduce pain and improve daily functions for some patients with the disorder but how it works is unclear.

Dr. Steven Galson at the FDA's center for drug evaluation and research says consumers need to understand that some patients did not experience benefit in clinical trials and more progress is needed in the treatment of the disorder.

Approval has been granted following two clinical trials, involving about 1,800 patients; doses of 300 milligrams or 450 milligrams per day have been suggested and the most common side effects of Lyrica include mild-to-moderate dizziness and sleepiness.

Also reported were blurred vision, weight gain, dry mouth, and swelling of the hands and feet which appear to be dose-related.

As Lyrica can impair motor function and affect concentration and attention the FDA advises patients to discuss with their doctor whether Lyrica might impair their ability to drive.

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

Lyrica has agreed to perform a study of the drug in children with fibromyalgia and another in women who are breastfeeding.