Living with Fibromyalgia, Drugs Approved to Manage Pain

After meeting on the Internet in 1997, Lynne Matallana and Karen Lee Richards discovered they had a lot in common. They both had seen numerous doctors before being diagnosed with fibromyalgia, a chronic condition characterized by fatigue and widespread pain in muscles and joints. They both had trouble finding medical information and support for coping with the illness. Seven months after meeting, they started gathering with five other people with fibromyalgia who also wanted to bring awareness to the issue.

"We called ourselves 'the pillow posse' because we would meet and have our pillows to support our aching bodies," Matallana says. Those gatherings grew into the National Fibromyalgia Association (NFA), an organization that now provides support, research information, medical education, and messages of hope to millions.

Fibromyalgia affects 2 to 4 percent of the population, according to the American College of Rheumatology (ACR). It mostly affects women, and tends to develop in early to middle adulthood. But men and children also can have it.

"One of the challenges is that fibromyalgia hasn't always been recognized as a specific illness," says Jeffrey Siegel, M.D., clinical team leader in FDA's Division of Anesthesia, Analgesia, and Rheumatology Products. "In 1990, the American College of Rheumatology developed criteria for diagnosing it, and this marked a major step forward in helping more people understand how to recognize the symptoms and how to treat them."

Approved Drugs

People with fibromyalgia have typically turned to pain medicines, antidepressants, muscle relaxants, and sleep medicines. In June 2007, Lyrica (pregabalin) became the first FDA-approved drug for specifically treating fibromyalgia; a year later, in June 2008, Cymbalta (duloxetine hydrochloride) became the second.

Both Lyrica and Cymbalta reduce pain and improve function in people with fibromyalgia. While those with fibromyalgia have been shown to experience pain differently from other people, the mechanism by which these drugs produce their effects is unknown. There is some data suggesting that these drugs affect the release of neurotransmitters in the brain. Neurotransmitters are chemicals that transmit signals from one neuron to another. Treatment with Lyrica or Cymbalta reduces the level of pain experienced by some people with fibromyalgia.

Lyrica, marketed by Pfizer Inc., was previously approved to treat seizures, as well as pain from damaged nerves that can happen in people with diabetes (diabetic peripheral neuropathy) and in those who develop pain following the rash of shingles. Side effects of Lyrica including sleepiness, dizziness, blurry vision, weight gain, trouble concentrating, swelling of the hands and feet, and dry mouth. Allergic reactions, although rare, can occur.

Cymbalta, marketed by Eli Lilly and Co., was previously approved to treat depression, anxiety, and diabetic peripheral neuropathy. Cymbalta's side effects include nausea, dry mouth, sleepiness, constipation, decreased appetite, and increased sweating. Like some other antidepressants, Cymbalta may increase the risk of suicidal thinking and behavior in people who take the drug for depression. Some people with fibromyalgia also experience depression.

Studies of both drugs showed that a substantial number of people with fibromyalgia received good pain relief, but there were others who didn't benefit.

Lyrica and Cymbalta are approved for use in adults 18 years and older. The drug manufacturers have agreed to study their drugs in children with fibromyalgia and in breastfeeding women.

Debilitating Effects

Matallana, who is now president of NFA, says she was a partner in an advertising firm when her life turned completely upside down because of her symptoms. "I finally had to stop working in 1995 and spent most of the next two years in bed," she says. Her husband quit his job and became a consultant working from home so that he could care for her.