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Bextra Information

Important Bextra Warning

Bextra was withdrawn from the United States market on April 7, 2005. The recall of Bextra by Pfizer is based on the potential for an increased risk of cardiovascular events (including heart attack and stroke) and serious skin reactions (toxic epidermal necrolysis and Stevens-Johnson syndrome) in patients taking Bextra compared to patients taking other nonsteroidal anti-inflammatory drugs (NSAIDs). 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. Valdecoxib may cause severe skin reactions including 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 Bextra, but are most likely to develop during the first 2 weeks of treatment. Tell your doctor if you are allergic to valdecoxib, sulfa drugs, aspirin and other non-steroidal anti-inflammatory medications (NSAIDs) such as ibuprofen and naproxen, 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 Bextra 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 Bextra. Talk to your doctor about the risk of taking Bextra.

Why is Bextra Prescribed?

Bextra is used to relieve the pain, tenderness, inflammation, swelling and stiffness caused by arthritis. Bextra may also be prescribed to treat painful menstrual periods. Bextra 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. For more information, read Bextra Description.

How is Bextra Taken?

Bextra comes in a tablet form and should be taken by mouth. It is usually taken with or without food once or twice a day. Bextra is available as 10 mg dosage or 20 mg dosage. To find out which dosage you require, speak to your doctor. For more information, read Bextra Dosage and Bextra Administration.

What Precautions should be taken before using Bextra?

Before taking Bextra:

  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: angiotensin-converting enzyme (ACE) inhibitors such as enalapril (Vasotec), fosinopril (Monopril), and lisinopril (Prinivil, Zestril); anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungals such as fluconazole (Diflucan) and ketoconazole (Nizoral); aspirin; diuretics ('water pills'); lithium (Eskalith, Lithobid); and oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have recently had coronary artery bypass graft surgery (CABG), a type of heart surgery) and if you have or have ever had ulcers, stomach bleeding, kidney or liver disease, heart failure, high blood pressure, swelling of legs and ankles, or asthma.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking Bextra, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking Bextra.
  • ask your doctor about the safe use of alcoholic beverages while you are taking Bextra. Alcohol may increase the risk of side effects from Bextra.
  • tell your doctor if you use tobacco products. Cigarette smoking may increase the risk of side effects from Bextra.

For a full list of precautions, see Bextra Warnings and Bextra Precautions.

What are the Side Effects of Bextra?

Bextra may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away

  • stomach pain
  • diarrhea
  • heartburn
  • back pain
  • headache

Some side effects of Bextra can be serious. The following symptoms are uncommon, but if you experience any of them, or those listed in the Important Bextra Warning at the top of this page, call your doctor immediately:

  • chest pain
  • black and tarry stools
  • red blood in stools
  • bloody vomit
  • vomiting material that looks like coffee grounds
  • unexplained weight gain
  • upset stomach
  • extreme tiredness
  • lack of energy
  • pain in the right upper part of the stomach
  • yellowing of the skin or eyes

Bextra may cause other side effects not mentioned here. For a more detailed discussion,see Bextra Side Effects. Call your doctor if you have any unusual problems while taking Bextra.

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