At the same time, a black box warning was added to valdecoxib's label noting that the drug can cause potentially fatal skin reactions, most likely in the first 2 weeks of therapy. Because the drug contains a sulfa moiety, patients who are allergic to sulfonamides are more likely to have the skin reactions, according to the FDA.
The CABG warning came on the heels of a report by Garret A. FitzGerald, M.D., director of the center for experimental therapeutics at the University of Pennsylvania, of a metaanalysis of surgical patients in two studies in which patients taking valdecoxib had more than twice the risk of stroke and MI, compared with placebo patients.