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 They also demonstrated that symptoms of fibromyalgia worsened when Lyrica was withdrawn.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.
Lyrica's Fibromyalgia Trials : People with fibromyalgia have been shown to experience pain differently from other people. Studies have shown that such patients have decreased pain after taking Lyrica, but the mechanism by which Lyrica produces such an effect is unknown.
The FDA approved Lyrica for the treatment of fibromyalgia based on two clinical trials that included about 1,800 fibromyalgia patients. The trials backed Lyrica's use in treating fibromyalgia at doses of 300 milligrams or 450 milligrams per day, according to the FDA.
Lyrica's Side Effects : In Lyrica's clinical trials for fibromyalgia treatment, the drug's most common side effects included mild to moderate dizziness and sleepiness. Blurred vision, weight gain, dry mouth, and swelling of the hands and feet also were also reported in the clinical trials.
Side effects appeared to correlate with the drug's dose, notes the FDA.
Lyrica can impair motor function and cause problems with concentration and attention. The FDA advises patients to talk to their doctor or other health care professional about whether the use of Lyrica may impair their ability to drive.
Lyrica is made by Pfizer, which has agreed to perform a study of the drug in children with fibromyalgia and a study in breastfeeding women.