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Drug Information Service

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Valdecoxib (Bextra®) cardiovascular risk and severe skin reactions < Print > 

December 14, 2004

The manufacture of valdecoxib, Pfizer, has added an increased warning of severe skin reactions and a contraindication for use in patients undergoing coronary artery bypass graft (CABG). Valdecoxib has caused severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (TENS). Of the 87 severe skin reaction cases reported, 20 were in patients with sulfa allergies. Valdecoxib contains sulfa and should be avoided in patients with sulfa allergies. Valdecoxib has also increased risk of thromboembolic events in CABG patients compared to placebo; therefore, it should not be used in this population.

Additional information about these changes is available at: You can find additional information about the cardiovascular effects of the COX-2 selective agents in the "Frequently Asked Questions: Why rofecoxib (Vioxx®) was removed from the market and alternatives" newsletter.