By Ed Zimney,
I’ve written about fibromyalgia before, and based on the number of comments, this is a topic of interest to many HealthTalk readers. And there’s now some good news to report. On June 21, 2007, after a priority review, the FDA approved Pfizer’s Lyrica (pregabalin) as the first drug ever approved for the treatment of fibromyalgia. Lyrica has already been on the market for the treatment of several other neurologic conditions, so it’s likely that some readers will already be familiar with it and they may want to post some comments about their experiences. Lyrica has been prescribed to over 5 million people worldwide for a variety of illnesses.
Lyrica reduces pain and improves function in patients with fibromyalgia and is approved to treat adults who are 18 years and older (Pfizer has agreed to do two post-approval studies, one in children and one in breastfeeding women). The mechanism of action is unknown, but researchers believe it affects the release of neurotransmitters, chemicals that transmit signals from one neuron to another, in the brain. People with fibromyalgia experience pain differently than those who don’t have the condition, and treatment with Lyrica reduces the level of pain in some patients.
The effectiveness of Lyrica was established in two randomized, placebo-controlled trials of approximately 1800 people with fibromyalgia. These trials showed that treatment with Lyrica in doses of 300-450 mg per day reduced pain and improved function. They also demonstrated that symptoms of fibromyalgia worsened when Lyrica was withdrawn. According to Pfizer, “In the clinical trials, Lyrica demonstrated rapid and sustained improvements in pain compared with placebo. In addition, patients taking Lyrica reported feeling better and improvements in physical function.”
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. Some reported allergic reactions include swelling of the face, mouth, lips, gums, tongue, neck and trouble breathing. Others may include rash, hives and blisters. Patients should be instructed to discontinue Lyrica and seek immediate medical care if they experience these symptoms.