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

Joaquín Quiralte, Blanca Sáenz de San Pedro, J José Fernando Florido
Annals of Allergy, Asthma & Immunology 2002, 89 (1): 63-6

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.

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