Bextra

Bextra was withdrawn from the U.S. market in 2005.

The manufacturer of Bextra has announced the voluntary withdrawal of the drug from the U.S. market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking non-steroidal anti-inflammatory drugs (Bextra is a "COX-2" selective non-steroidal anti-inflammatory drug) and safety concerns of an increased risk of rare but serious skin reactions in patients taking Bextra.

Bextra was withdrawn from the U.S. market in 2005.

Bextra is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Bextra works by reducing substances in the body that cause inflammation, pain, and fever.

Bextra is used to reduce pain, inflammation, and stiffness caused by osteoarthritis and adult rheumatoid arthritis. Bextra is also used to treat painful menstruation.

Bextra may also be used for purposes other than those listed in this medication guide.

Take Bextra exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Bextra can be taken with or without food or milk. Follow your doctor's instructions.

The manufacturer of Bextra has announced the voluntary withdrawal of the drug from the U.S. market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking non-steroidal anti-inflammatory drugs (Bextra is a "COX-2" selective non-steroidal anti-inflammatory drug) and safety concerns of an increased risk of rare but serious skin reactions in patients taking Bextra.

Bextra should not be used for the treatment of pain after coronary artery bypass surgery (CABG). The use of Bextra in such patients has led to an increased incidence of cardiovascular events, deep surgical infections and wound complications. Talk to your doctor before taking Bextra if you are being treated for pain associated with CABG.

Before taking Bextra, tell your doctor if you

• smoke;
• drink alcohol;
• have an ulcer or bleeding in the stomach;
• have liver disease;
• have kidney disease;
• have asthma;
• have congestive heart failure;
• have fluid retention;
• have heart disease;
• have high blood pressure;
• have a coagulation (bleeding) disorder or are taking an anticoagulant (blood thinner) such as warfarin (Coumadin); or
• are taking a steroid medicine such as prednisone (Deltasone and others), methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred, and others), and others.

You may not be able to take Bextra, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions, or are taking any of the medicines, listed above.

Other, less serious side effects may be more likely to occur. Continue to take Bextra and talk to your doctor if you experience

• diarrhea;
• nausea or upset stomach; or
• headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose as directed. Do not take a double dose of this medication unless otherwise directed by your doctor.

Symptoms of a Bextra overdose include drowsiness, nausea, vomiting, and stomach pain.

There are no restrictions on food, beverages, or activity while taking Bextra unless otherwise directed by your doctor.

Before taking Bextra, tell your doctor if you are taking any of the following drugs:

• aspirin or another salicylate (form of aspirin) such as salsalate (Disalcid), choline salicylate-magnesium salicylate (Trilisate, Tricosal, others), and magnesium salicylate (Doan's, Bayer Select Backache Formula, others);
• an over-the-counter cough, cold, allergy, or pain medicine that contains dextromethorphan, aspirin, ibuprofen, naproxen, or ketoprofen;
• a diuretic (water pill) such as furosemide (Lasix), hydrochlorothiazide (HydroDiuril, others), chlorothiazide (Diuril, others), chlorthalidone (Hygroton, Thalitone), and others;
• an angiotensin-converting-enzyme inhibitor (ACE inhibitor) such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), and others;
• a steroid medicine such as prednisone (Deltasone and others), methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred, and others), and others;
• an anticoagulant (blood thinner) such as warfarin (Coumadin);
• diazepam (Valium);
• phenytoin (Dilantin);
• glyburide (DiaBeta, others);
• an oral contraceptive (Micronor, Triphasil, Levlen, others);
• omeprazole (Prilosec, Zegerid);
• lithium (Eskalith, Lithobid, others); or
• fluconazole (Diflucan) or ketoconazole (Nizoral).

You may not be able to take Bextra, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with Bextra. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines including vitamins, minerals, and herbal products.