Bextra

Generic Name: valdecoxib (val deh COCK sib)

What is the most important information I should know about 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Bextra was withdrawn from the U.S. market in 2005.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.

Do not take Bextra without first talking to your doctor if you have experienced asthma, hives, or an allergic reaction after taking a sulfa-based medication such as sulfamethoxazole (Bactrim, Septra, Gantanol, and others) or sulfisoxazole (Gantrisin); aspirin; or another NSAID such as celecoxib (Celebrex), ibuprofen (Motrin, Advil, Nuprin, and others), naproxen (Aleve, Naprosyn, Anaprox), ketoprofen (Orudis KT, Orudis, Oruvail), diclofenac (Voltaren, Cataflam), diflunisal (Dolobid), etodolac (Lodine, Lodine XL), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), meloxicam (Mobic), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), or tolmetin (Tolectin). You may experience a similar reaction to Bextra. Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; bloody vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of the skin or eyes;”flu-like” symptoms; or unusual bruising or bleeding. These symptoms could be early signs of dangerous side effects. Serious skin reactions have occurred in patients taking Bextra. These reactions tend to occur within the first two weeks of treatment, but may occur at any time during treatment. Stop taking Bextra and contact your doctor immediately if you develop a skin rash; hives; itching; difficulty breathing; swelling of the lips, tongue or face; or other symptoms of an allergic reaction.

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Bextra was withdrawn from the U.S. market in 2005.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

What should I discuss with my healthcare provider before taking Bextra?

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.

Do not take Bextra without first talking to your doctor if you have experienced asthma, hives, or an allergic reaction after taking a sulfa-based medication such as sulfamethoxazole (Bactrim, Septra, Gantanol, and others) or sulfisoxazole (Gantrisin); aspirin; or another NSAID such as celecoxib (Celebrex), ibuprofen (Motrin, Advil, Nuprin, and others), naproxen (Aleve, Naprosyn, Anaprox), ketoprofen (Orudis KT, Orudis, Oruvail), diclofenac (Voltaren, Cataflam), diflunisal (Dolobid), etodolac (Lodine, Lodine XL), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), meloxicam (Mobic), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), or tolmetin (Tolectin). You may experience a similar reaction to 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 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.

Bextra is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Bextra should not be taken late in pregnancy (the third trimester) because it may affect the formation of the baby’s heart. Do not take Bextra without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether Bextra passes into breast milk. Do not take Bextra without first talking to your doctor if you are breast-feeding a baby. If you are over the age of 65 years, you may be more likely to experience side effects from Bextra. You may require a lower dosage or special monitoring during your therapy.

How should I take Bextra?

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.

Take each dose with a full glass of water.

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

Store Bextra at room temperature away from moisture and heat.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention.

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

What should I avoid while taking Bextra?

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

What are the possible side effects of Bextra?

Serious skin reactions have occurred in patients taking Bextra. These reactions tend to occur within the first two weeks of treatment, but may occur at any time during treatment. Stop taking Bextra and contact your doctor immediately if you develop a skin rash; hives; itching; difficulty breathing; swelling of the lips, tongue or face; or other symptoms of an allergic reaction. Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; bloody vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of the skin or eyes;”flu-like” symptoms; or unusual bruising or bleeding. These symptoms could be early signs of dangerous side effects.

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.

What other drugs will affect Bextra?

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;

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.