General Information

On April 7, 2005, the Food and Drug Administration (FDA) asked Pfizer to voluntarily remove Bextra (valdecoxib) from the market. This request was made citing the potential for increased risk of cardiovascular (CV) events and the well described, serious, potential life-threatening gastrointestinal (GI) bleeding outweighs the benefit of Bextra treatment.

Bextra is approved to treat the signs and symptoms of osteoarthritis (OA), adult rheumatoid arthritis (RA) and the treatment of pain associated with menstrual cramping. Bextra has previously been approved for relief from arthritis pain. Bextra is a once-daily treatment in an oral tablet formulation.

More than 23 million Americans suffer from some form of arthritis. The most prevalent is OA, which affects approximately 21 million Americans. This chronic disorder is characterized by the degeneration of joint cartilage and bone, which can lead to severe pain and stiffness. RA, which affects joint lining, cartilage and bone, affects over two million Americans.

Clinical Results

The approval of Bextra is supported by results from clinical studies lasting from three to six months. In five double-blind trials with 3,918 subjects with OA of the knee or hip, Bextra was significantly superior to placebo and comparable to a naproxen control, in treating pain and stiffness and improving functional measures. In four double-blind trials with 3,444 subjects with RA, Bextra demonstrated significantly better results than placebo and comparable results to naproxen in improving the tenderness and number of swollen joints and the level of pain. Bextra was evaluated for treatment of menstrual pain in two placebo-controlled studies. The onset, magnitude and duration of analgesic effect of a 20 mg dose of Bextra was comparable to a 500 mg dose of naproxen.

In all studies, Bextra was overall well tolerated and exhibited a significantly better gastrointestinal safety profile than other conventional nonsteroidal anti-inflammatory drugs (NSAIDs), such as naproxen, ibuprofen and diflonac.

Side Effects

Adverse events associated with the use of Bextra may include (but are not limited to) the following:

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• Dyspepsia
• Headache
• Abdominal pain
• Nausea
• Diarrhea

Mechanism of Action

Bextra (valdecoxib) is an NSAID that exhibits anti-inflammatory, analgesic and antipyretic properties. These effects are due to the inhibition of COX-2, which in turn inhibits prostaglandin synthesis.