Brand Name: Bextra®

Active Ingredient: valdecoxib

Strength(s): 10 mg and 20 mg

Dosage Form(s): Tablets

Company Name: G.D. Searle & Co.

Availability: Prescription only *

Date Approved by FDA: November 16, 2001

Valdecoxib is a prescription drug used in the treatment of osteoarthritis, rheumatoid arthritis, and painful menstruation and menstrual symptoms. It is classified as a nonsteroidal anti-inflammatory drug, or NSAID, and should not be taken by anyone allergic to these types of medications.

Valdecoxib was manufactured and marketed under the brand name Bextra by G. D. Searle & Company. It was available by prescription in tablet form until 2005, when it was removed from the market due to concerns about possible increased risk of heart attack and stroke.

Uses

Since its registration, Bextra was prescribed for pain associated with arthritis, menstrual discomfort, and other ailments

Side-effects and withdrawal

On April 7, 2005, Pfizer withdrew Bextra from the U.S. market on recommendation by the FDA, citing an increased risk of heart attack and stroke and also the risk of a serious, sometimes fatal, skin reaction. This was a result of recent attention to prescription NSAIDs, such as Merck's Vioxx. Other reported side-effects were angina and Stevens-Johnson syndrome.

Pfizer first acknowledged cardiovascular risks associated with Bextra in October of 2004. The American Heart Association soon after was presented with a report indicating patients using Bextra while recovering from heart surgery were 2.19 times more likely to suffer a stroke or heart attack than those taking placebos.

Recently in a large study published in JAMA 2006, Valdecoxib appears less adverse for renal (kidney) disease and heart arrhythmia compared to Vioxx, however elevated renal risks was slightly suggested. Systematic review of adverse renal and arrhythmia risk of celecoxib and other COX-2 inhibitors, in JAMA 2006

General Precautions with Bextra:

Bextra and other NSAID medications can cause serious problems such as liver damage. Some of the warning signs of liver damage are nausea, vomiting, tiredness, loss of appetite, itching, yellow coloring of skin or eyes, “flu-like” symptoms and dark urine. If this happens, stop taking Bextra and call your doctor right away.

Bextra can cause fluid retention (holding of water in your body). Fluid retention can be a serious problem if you have high blood pressure or heart failure. Do not use Bextra if you have asthma and are allergic to aspirin. If an aspirin-sensitive asthmatic takes aspirin it can cause severe narrowing of the airway (bronchospasm), and even death. The same reactions to aspirin and other NSAID medicines happened in aspirin-sensitive patients.

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