Today in the US the FDA has approved the first drug for Fibromyalgia, called Lyrica. This is an anti-convulsant drug that was previously approved by the FDA for the treatment of seizures, post-herpetic pain and diabetic neuropathy. The FDA has also added Fibromyalgia information to help people with this illness.
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.”
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.
For more information from FDA, read here.
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