Fibromyalgia Drug Wins Approval

Tuesday, July 10, 2007

The first drug approved to treat fibromyalgia was given the go-ahead for marketing by the Food and Drug Administration last month. Lyrica, made by Pfizer, was approved several years ago to treat epilepsy, shingles pain and nerve pain related to diabetes. The federal agency okayed the new use after clinical trials showed some fibromyalgia patients had improved as well.

Fibromyalgia, a disorder that can cause pain, fatigue and interrupted sleep, affects an estimated 3 million to 6 million Americans. It can occur on its own, or it can be a problem secondary to autoimmune disorders such as lupus and osteoarthritis, said Philip Mease, chief of rheumatology at the Swedish Medical Center in Seattle. (As a clinical investigator for Lyrica, Mease has accepted fees from Pfizer but has not been compensated to speak with reporters about the drug.)

Because there is no definitive test for the condition, fibromyalgia is a diagnosis of exclusion: Doctors make the diagnosis by conducting physical examinations, evaluating symptoms and ruling out other conditions.

Other drugs shown effective in treating fibromyalgia include the antidepressant Cymbalta. Doctors often suggest exercise and acupuncture in addition to drugs, Mease said.

Without insurance, the drug could cost $4 or more per day, based on Drugstore.com prices. Side effects include dizziness, sleepiness, blurred vision, weight gain, dry mouth and swelling of the hands and feet. The FDA advises patients to ask their doctor about the safety of driving while taking Lyrica.

-- Francesca Lunzer Kritz


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