Living with Fibromyalgia, First Drug Approved Printer-friendly PDF (341 KB)
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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."
People with fibromyalgia have typically turned to pain medicines, antidepressants, muscle relaxants, and sleep medicines. On June 21, 2007, Lyrica (pregabalin) became the first FDA-approved drug for specifically treating fibromyalgia. Marketed by Pfizer Inc., Lyrica reduces pain and improves function in patients with fibromyalgia. While patients with fibromyalgia have been shown to experience pain differently from other people, the mechanism by which Lyrica produces its effects is unknown. The drug was already approved to treat seizures, as well as pain from damaged nerves that can happen in people with diabetes and in those who develop pain following the rash of shingles.
"People who take Lyrica should be aware of important side effects, including sleepiness and dizziness," Siegel says. Other side effects seen in patients taking Lyrica include swelling of the hands and feet, and allergic reactions.
"Studies showed that a substantial number of patients with fibromyalgia received good pain relief with Lyrica, but there are other patients who didn't benefit," Siegel says. "This new approval marks an important advance, and we think it's reason for optimism. But we still have much more progress to make."
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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.
"I had a yoga instructor coming to my house three times a week to help me get out of bed. The pain and exhaustion were so bad that there were days that the only activity I was able to do was walk from my bed to the mailbox and back to bed. Each day seemed like an eternity and so I had to focus on just getting through one day at a time."
People with fibromyalgia can experience pain anywhere, but common sites of pain include the neck, shoulders, back, hips, arms, and legs. In addition to pain and fatigue, other symptoms include difficulty sleeping, morning stiffness, headaches, painful menstrual periods, tingling or numbness of hands or feet, and difficulty thinking and remembering. Some people with the condition may also experience irritable bowel syndrome, pelvic pain, restless leg syndrome, and depression.
What Causes Fibromyalgia?
Scientists believe that the condition may be due to injury, emotional distress, or viruses that change the way the brain perceives pain, but the exact cause is unclear. People with rheumatoid arthritis, lupus, and spinal arthritis may be more likely to have the illness.
According to ACR, people with fibromyalgia can have abnormal levels of Substance P in their spinal fluid. This chemical helps transmit and amplify pain signals to and from the brain.
Researchers are looking at the role of Substance P and other neurotransmitters, and studying why people with fibromyalgia have increased sensitivity to pain and whether there is a gene or genes that make a person more likely to have it.
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Getting a Diagnosis
Matallana says she felt her suffering was being dismissed as she went from doctor to doctor looking for answers.
"Many doctors suggested that it was just stress," she says. "Some of them even made references that it was all in my head. I was eventually misdiagnosed as having Lupus."
When Matallana was 39, a rheumatologist who was just starting his practice, finally diagnosed her with fibromyalgia. "With my doctor's help, I started to feel better," she says. "It made all the difference that I had a health care provider who could give me insights as to what fibromyalgia research was showing, and that there were other people feeling what I was feeling."
Family physicians, general internists, and rheumatologists are the doctors who typically treat fibromyalgia. There is no diagnostic test for it. Doctors make a diagnosis by conducting physical examinations, evaluating symptoms, and ruling out other conditions. For example, fibromyalgia can be distinguished from arthritis because arthritis causes inflammation of tissues and joints and fibromyalgia does not. Another condition with similar symptoms, hypothyroidism, can be confirmed with a blood test.
Diagnostic criteria set forth by ACR include a history of widespread pain for at least three months and pain in at least 11 of 18 tender point sites.
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First Drug Approved
Drug name: Lyrica (pregabalin)
Manufactured by: Pfizer Inc.
Approval date: June 21, 2007
Approved for: Lyrica is approved for treating fibromyalgia in adults who are 18 years and older. Pfizer has agreed to perform a study of the drug in children with fibromyalgia and a study in breastfeeding women.
How it works: Lyrica reduces pain and improves function in patients with fibromyalgia. The mechanism of action is unknown, but there is some data suggesting that it has effects on the release of neurotransmitters in the brain. Neurotransmitters are chemicals in the brain that transmit signals from one neuron to another. People with fibromyalgia experience pain differently than people who don't have the condition. Treatment with Lyrica reduces the level of pain in some patients.
Effectiveness: The effectiveness of Lyrica in treating fibromyalgia was established in two randomized, placebo-controlled trials of approximately 1800 people. These trials showed that treatment with Lyrica in doses of 300-450 mg per day reduced pain and improved function in patients with fibromyalgia. They also demonstrated that symptoms of fibromyalgia worsened when Lyrica was withdrawn.
Safety: The most common side effects of Lyrica include dizziness and sleepiness, blurry vision, weight gain, trouble concentrating, swelling of the hands and feet, and dry mouth. Allergic reactions can also occur. These are rare, but potentially serious. FDA advises patients to talk with their doctors about whether using Lyrica will impair their ability to drive.
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More than Medicine
People with fibromyalgia may find relief of symptoms with pain relievers, sleep medicines, antidepressants, muscle relaxants, and anti-seizure medications. But medication is just one part of the treatment approach.
What helped Matallana was a combination of medicines for pain and sleep, treatment for some of the overlapping conditions like migraines and irritable bowel syndrome, and a combination of water therapy, massage and yoga. Walking, jogging, biking, gently stretching muscles, and other exercises also can be helpful.
Emotional support also is essential, Matallana says. "My husband always believed me, and when you have that kind of support it makes a difference. It's really about facing chronic pain for the rest of your life. So dealing with the emotional impact and not just the physical side is very important."
For More Information
National Institute of Arthritis and Musculoskeletal and Skin Diseases
www.niams.nih.gov/hi/topics/fibromyalgia/fffibro.htm
American College of Rheumatology
www.rheumatology.org/public/factsheets/fibromya_new.asp
National Fibromyalgia Association
www.fmaware.org
Fibromyalgia Network
www.fmnetnews.com
Date Posted: June 21, 2007
http://www.fda.gov/consumer/updates/fibromyalgia062107.html
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