1 - Lyrica is the first FDA-approved medicine for fibromyalgia.
Lyrica (pronounced LEER-i-kah) was approved for the treatment of fibromyalgia in adults 18 years and older on June 21, 2007. The drug, marketed by Pfizer, was previously approved for the management of diabetic peripheral neuropathy, post-herpetic neuralgia, and as an additional therapy for adults with partial onset seizures. Until the approval of Lyrica capsules, no medicine was specifically approved to treat fibromyalgia. Symptoms of fibromyalgia had been treated with:
2 - Lyrica reduces pain and improves function in fibromyalgia patients.
Exactly how Lyrica works is unknown. Fibromyalgia symptoms have been linked to changes in the brain that influence how people feel pain. Fibromyalgia patients experience a heightened sensitivity to stimuli that are not normally painful to others. Some data suggests Lyrica binds to a protein in nerve cells that is responsible for the heightened sensitivity.
3 - Prior to FDA approval, the effectiveness of Lyrica for treating fibromyalgia was established by two clinical trials involving 1,800 people.
Study results from the two randomized, double-blind, placebo-controlled clinical trials showed that doses of 300 mg or 450 mg of Lyrica per day improved fibromyalgia symptoms (i.e., reduced pain and improved function) as early as the first week of treatment. When patients stopped taking Lyrica, fibromyalgia symptoms worsened.
4 - During clinical trials, common side effects were reported for patients taking Lyrica compared to placebo.
According to Pfizer, common side effects reported in patients taking Lyrica included:
- dry mouth
- blurred vision
- weight gain
- swelling of hands and feet
- exaggerated feeling of happiness or wellness
- balance disorder
- increased appetite
- difficulty with concentration/attention
Because of the possibility of dizziness or drowsiness, the drug may impair one's ability to drive or operate complex machinery.
5 - Lyrica may cause rare but potentially serious allergic reactions, such as angioedema and hypersensitivity.
Some patients reported allergic reactions to Lyrica, including swelling of the face, mouth, lips, gums, tongue, and neck. Others experienced trouble breathing, rash, hives, and blisters. If any of these symptoms occur, patients should stop taking Lyrica immediately and seek medical care.
6 - Lyrica may interact with other medications.
Patients must inform their doctor about all medications that they take, prescription or non-prescription, as well as any supplements.
Possible interactions can occur with:
- Parkinson's disease medications
- diabetes medications
- medicines used to help you sleep or relax, such as lorazepam (Ativan), alprazolam (Xanax), or diazepam (Valium)
- pain medications, such as morphine (MS Contin) or codeine
- phenothiazines used for certain mental disorders or for nausea/vomiting
- tricyclic antidepressants
7 - Patients who have had prior drug or alcohol problems may be more likely to misuse Lyrica.
As with any prior significant medical problem, patients who have abused or been addicted to drugs or alcohol in the past should inform their doctor. Because of the increased possibility of misuse of Lyrica in these individuals, closer monitoring may be necessary or another treatment may be preferable.
8 - Patients taking Lyrica should not stop the drug without consulting their doctor.
Lyrica should be taken at the prescribed dosage. If a dose of Lyrica is missed and it's almost time for the next dose, skip the missed dose. Two doses of Lyrica should not be taken together. Patients should continue taking the drug even after experiencing pain relief. They should also plan ahead for refills so that the prescription does not run out.
9 - More research will follow on Lyrica.
Pfizer has agreed to study the use of Lyrica in children with fibromyalgia. Another study will be planned for breastfeeding women. As it stands, women who are pregnant or plan to become pregnant should notify their doctor before starting the drug. No adequate, well-controlled studies have been conducted in pregnant humans, and use is only appropriate when the potential benefit to the mother outweighs possible risk to the fetus.
Men who are planning for fatherhood should also talk with their doctor before taking Lyrica. Studies showed that the drug made male animals less fertile. Also, birth defects occurred in the offspring of male animals who were treated with pregabalin.
10 - It is important to discuss potential benefits versus risks of Lyrica with your doctor.
Patients must fully understand dosage, directions, side effects, and potential serious adverse events associated with Lyrica. While it may be a very beneficial drug for some patients with fibromyalgia, precautions for safe use must be followed.
FDA Approves First Drug for Treating Fibromyalgia. FDA. June 21, 2007.
Living with Fibromyalgia, First Drug Approved. FDA Consumer Update. June 21, 2007.
The Official Site of Lyrica. June 25,2007.
FDA Patient Information Sheet. Pregabalin (marketed as Lyrica). November 21, 2005.