Bextra  (Valdecoxib) 10mg & 20mg Tablets

Manufacturer: Pharmacia, Pfizer

Indication(s):  Treating signs and symptoms of osteoarthritis, rheumatoid arthritis, and menstrual pain and cramping.

Pharmacology:  Valdecoxib is a nonsteroidal anti-inflammatory drug (NSAID). Valdecoxib inhibits prostaglandin synthesis by selectively inhibiting the cyclooxygenase-2 (COX-2) isoenzyme; however, at therapeutic plasma concentrations in humans, it does not inhibit the cyclooxygenase-1 (COX-1) isoenzyme. Inhibition of the COX-2 enzyme results in decreased arthritis pain and inflammation.

Usual Dosage:

WebRx Editorial Notes:  Valdecoxib may be taken with or without food according to the manufacturer's recommendations.  This drug represents another in the class of Cox-2 inhibitors which are presumably safer on the stomach than older NSAIDs.  There is some debate as to whether older, less expensive medications would be more appropriate for patient's with no pre-disposing factors that might lead to gastrointestinal side effects.

Note:  On November 13th, 2002 a new warning was issued regarding Bextra.  See below.

CONTRAINDICATIONS:  Bextra should not be given to patients who have demonstrated allergic-type reactions to sulfaonamides.

WARNINGS - Serious Skin Reactions:  Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported through postmarketing surveillance in patients receiving Bextra.  As these reactions can be life threatening, Bextra should be discontinued at the first appearance of skin rash or any other sign of hypersensititvity.

WARNINGS - Anaphylactoid Reactions:  In postmarketing experience, cases of hypersensitivity reactions (anaphylactic reactions and angioedema) have been reported in patients receiving Bextra.  These cases have occurred in patients with and without a history of allergic-type reactions to sulfonamides.

ADVERSE REACTIONS - Postmarketing Experience:  The following reactions have been identified during postmarketing use of Bextra.  These reactions have been chosen for inclusion either due to their seriousness, reporting frequency, possible causal relationship to Bextra, or a combination of these factors.  Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

2002 WebRx Pharmacy Palace