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 They also demonstrated that symptoms of fibromyalgia worsened when Lyrica was withdrawn.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.

http://www.fda.gov/consumer/updates/fibromyalgia062107.html