Medications and Drugs
Please Note: This Drug has been discontinued.
NOTE: April 7, 2005, Pfizer agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the with the FDA. For more information, please read the FDA press release.
Pharmacy Author: Omudhome Ogbru, Pharm.D.
Medical Editor: Jay Marks, M.D.
GENERIC NAME: valdecoxib
BRAND NAME: Bextra
DRUG CLASS AND MECHANISM: Valdecoxib is an oral drug that belongs to the family of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs are used primarily to treat pain and arthritis. Other NSAIDs include aspirin and aspirin-related drugs, ibuprofen (Motrin), indomethacin (indocin), naproxen (Naprosyn), diclofenac (Voltaren), sulindac (Clinoril), ketoprofen (Orudis), etc. Valdecoxib works by altering the production of prostaglandins, chemicals manufactured by the body that promote the inflammation of arthritis and cause the pain, swelling and tenderness of arthritic joints. Valdecoxib, like the newer NSAIDs celecoxib (Celebrex) and rofecoxib (Vioxx), blocks one of the enzymes that makes prostaglandins (cyclooxygenase 2), resulting in lower concentrations of prostaglandins. As a consequence, pain, swelling and tenderness of joints due to arthritis are reduced. Valdecoxib (like celecoxib and rofecoxib) differs from most other NSAIDs in that it causes less inflammation and ulceration of the stomach and intestine (at least with short-term treatment) and does not interfere with the clotting of blood.
PRESCRIPTION: Yes
GENERIC AVAILABLE: No
PREPARATIONS: Oblong white tablets containing 10 or 20mg of valdecoxib.
STORAGE: Valdecoxib tablets should be stored at room temperature, 59-86 °F (15-30 °C).
PRESCRIBED FOR: Valdecoxib is used for the relief of pain, fever, swelling, and tenderness caused by osteoarthritis and rheumatoid arthritis, but it does not prevent the destruction of joints by the arthritis. Valdecoxib also is approved for the relief of pain of menstrual cramps (primary dysmenorrhea).
DOSING: For osteoarthritis or rheumatoid arthritis, the usual approved dose of valdecoxib is 10 mg once daily. For dysmenorrhea, the dose is 20 mg twice daily. Valdecoxib may be taken with or without food.
DRUG INTERACTIONS: NSAIDs can reduce the actions of diuretics such as furosemide (Lasix) and hydrochlorothiazide (Hydrodiuril) in some patients and lead to retention of water.
Fluconazole (Diflucan), ketoconazole (Nizoral), and lithium (Eskalith) may increase the concentration of valdecoxib in the body by inhibiting its breakdown in the liver.
PREGNANCY: In pregnant animals, valdecoxib has been shown to cause fetal abnormalities. Although the use of valdecoxib by pregnant women has not been studied carefully, fetal abnormalities have been reported in women who took valdecoxib during pregnancy. Valdecoxib should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Valdecoxib should be avoided during late pregnancy. Valdecoxib should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Valdecoxib should be avoided during late pregnancy.
NURSING MOTHERS: The use of valdecoxib in nursing mothers has not been evaluated.
SIDE EFFECTS: The most common side effects of valdecoxib are headache, abdominal pain, diarrhea, nausea, flatulence and insomnia. Other side effects include fainting, kidney failure, heart failure, fluid retention, aggravation of hypertension, chest pain, ringing in the ears, deafness, stomach and intestinal ulcers, bleeding, blurred vision, anxiety, photosensitivity, weight gain, water retention, flu-like symptoms, drowsiness and weakness.
Very serious allergic reactions have been reported with valdecoxib. It is recommended that patients who experience a rash after beginning therapy with valdecoxib should discontinue valdecoxib immediately and seek the advise of their physician. Although valdecoxib is not a sulfonamide itself (unlike celecoxib), it is recommended that patients with an allergy to sulfonamides ("sulfas") should not take valdecoxib.
Although the chances of stomach or intestinal ulceration or bleeding with valdecoxib are low, a small risk of these side effects remains. Patients taking valdecoxib should report any symptoms or signs of ulceration or bleeding such as abdominal pain or black stools to their doctor
Reference: FDA Prescribing Information
Last Editorial Review: 4/7/2005
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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