Safety of selective cyclooxygenase-2 inhibitor rofecoxib in patients with NSAID-induced cutaneous reactions.

BACKGROUND: Controlled oral challenge with nonsteroidal anti-inflammatory drugs (NSAIDs) is the only definite way to diagnose the different clinical manifestations of NSAID sensitivity. OBJECTIVE: To evaluate the safety of selective cyclooxygenase-2 inhibitor rofecoxib in a patient population with NSAID-induced skin reactions. METHODS: We prospectively conducted single-blind, placebo-controlled, oral challenges (SBPCOCs) with rofecoxib in 15 patients with challenge-proven NSAID-induced cutaneous reactions. RESULTS: Fifteen patients (9 men and 6 women, ranging in age from 14 to 60 years) had positive SBPCOC response to at least one of the following NSAIDs: aspirin (in 46.7% of cases), nimesulide (in 40% of cases), and diclofenac (in the remaining 13.3% of cases). During controlled challenges, 8 patients (53.3%) had urticaria (1 of them with associated angioedema); 6 (40%) had facial angioedema; and 1 (6.6%) had nonurticarial rash. Controlled oral challenge with rofecoxib were well tolerated in all patients. CONCLUSION: Rofecoxib did not cross-react with aspirin and other NSAIDs in patient with NSAID-induced skin reactions. A tolerance observed to this drug during SBPCOCs will indicate a safe alternative in this patient-group.