Cutaneous adverse reactions to valdecoxib distinct from Stevens-Johnson syndrome and toxic epidermal necrolysis.

OBJECTIVE To assess the type of severe skin reactions caused by valdecoxib treatment. DESIGN Case registry of severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. SETTING All hospitals in Germany that treat patients with severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. PATIENTS Five case notifications of Stevens-Johnson syndrome after the use of valdecoxib were reevaluated following the withdrawal of valdecoxib on April 7, 2005. RESULTS A thorough review of all reported cases of severe skin reactions caused by valdecoxib revealed extensive erythematous, targetlike skin eruptions in addition to facial edema and dyspnea. Histologic changes, clinical pattern, and outcome demonstrated a distinct disease entity. CONCLUSION Valdecoxib induces severe skin reactions different from those of Stevens-Johnson syndrome and toxic epidermal necrolysis in clinical and histopathologic findings, course, and outcome.