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Valdecoxib

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IMPORTANT WARNING:

On April 7, 2005, Pfizer, Inc., announced that valdecoxib (Bextra) will no longer be available in the United States. This action is based on advice from the Food and Drug Administration (FDA) about the potential for an increased risk of cardiovascular events (including heart attack and stroke) and serious skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme) in patients taking valdecoxib compared to patients taking other nonsteroidal anti-inflammatory drugs (NSAIDs). Additionally, the FDA states that Bextra has not been shown to offer any unique advantages compared with the other available NSAIDs. If you are currently taking Bextra, you should call your doctor to discuss switching to another treatment. For more information visit the FDA website: http://www.fda.gov/cder/drug/infopage/COX2/default.htm.

Valdecoxib may cause severe skin reactions including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis. These skin reactions may affect large areas of the body and may cause serious illness or death. The skin reactions may develop at any time during your treatment with valdecoxib, but are most likely to develop during the first 2 weeks of your treatment. Tell your doctor if you are allergic to valdecoxib, sulfa drugs, aspirin and other non-steroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn), or any other medications. Also tell your doctor if you have ever had a severe rash. If you experience any of the following symptoms, stop taking valdecoxib and call your doctor immediately: rash; red skin; sores on the inside of your mouth, nose, eyes, throat, anus, or genital area; fever; chills; flu-like symptoms; hives; itching; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs; difficulty breathing or swallowing; or hoarseness.

Other medications similar to valdecoxib may also cause severe skin reactions, but the risk appears to be greater with valdecoxib. Talk to your doctor about the risk of taking valdecoxib.

Why is this medication prescribed?

Valdecoxib is used to relieve the pain, tenderness, inflammation (swelling), and stiffness caused by arthritis and to treat painful menstrual periods. Valdecoxib is in a class of nonsteroidal anti-inflammatory medications called COX-2 inhibitors. It works by stopping the body's production of a substance that causes pain and inflammation.

How should this medicine be used?

Valdecoxib comes as a tablet to take by mouth. It is usually taken with or without food once or twice a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take valdecoxib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor. Your doctor may order certain lab tests to check your body's response to valdecoxib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

Bextra®

Notes:

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EditText of this page (last edited February 27, 2008)