1st U.S. Drug Approved for Fibromyalgia

Lyrica (pregabalin) has been approved by the U.S. Food and Drug Administration to treat fibromyalgia. It's the first drug approved in the United States to treat the condition that affects up to 6 million Americans, the agency said Thursday. People with fibromyalgia usually have chronic pain, muscle stiffness, fatigue, and sleep problems. The disorder affects more women than men, and commonly develops in early-to-middle adulthood.

Lyrica was approved for fibromyalgia following clinical trials involving about 1,800 people, although not all participants were helped by the drug, the agency said. Lyrica, manufactured by Pfizer, Inc., is already approved to treat partial seizures, and pain from shingles and diabetic neuropathy. Lyrica's main action affects the central nervous system.

What are the possible side effects of LYRICA?
• dizziness and sleepiness.
• eyesight problems.
• weight gain and swelling of the hands and feet (edema).
Weight gain may affect the management of diabetes. Weight
gain and swelling can also be a serious problem for people with
heart problems.
• unexplained muscle problems, such as muscle pain,
soreness, or weakness. If you develop these symptoms,
especially if you also feel sick and have a fever, tell your
doctor right away.

The most common side effects of LYRICA are:
• dizziness
• blurry vision
• weight gain
• sleepiness
• trouble concentrating
• swelling of hands and feet
• dry mouth

LYRICA caused skin sores in animals. Although skin sores were not seen in studies in people, if you have diabetes, you should pay extra attention to your skin while taking LYRICA and tell your doctor of any sores or skin problems.

LYRICA may cause some people to feel “high.” Tell your doctor, if you have abused prescription medicines, street drugs, or alcohol in the past.

These are not all the side effects of LYRICA. For more information, ask your doctor or pharmacist.

What are the ingredients In LYRICA?
Active ingredient: pregabalin
Inactive ingredients: lactose monohydrate, cornstarch, talc;
Capsule shell: gelatin and titanium dioxide; Orange capsule shell: red iron oxide; White capsule shell: sodium lauryl sulfate, colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. Imprinting ink: shellac, black iron oxide, propylene glycol, potassium hydroxide.