Safety of rofecoxib in subjects with a history of adverse cutaneous reactions to aspirin and/or non-steroidal anti-inflammatory drugs

Background: Adverse reactions to non-steroidal anti-inflammatory drugs (NSAID)s are frequent, and the need to identify a safe alternative drug is a common problem in clinical practice. Objective: To assess the tolerability ofrofecoxib, a drug that specifically inhibits COX-2, in a group of NSAID-sensitive patients. Methods: One-hundred and four subjects (29 males and 75 females, mean age 35.6 ± 14.1) were enrolled. All subjects had experienced one or more episode characterized by cutaneous symptoms (erythema, and/or urticaria angioedema) following the assumption of NSAIDs; 92 subjects experienced reactions to only one NSAID (single intolerance: SI) and 12 subjects had reactions to multiple NSAIDs (multiple intolerance: MI). Rofecoxib was challenged at the following dosages: 1/4 of 25 mg (6.25mg), 1/4 of 25mg, and 1/2 of 25mg (12.5mg), at intervals of 1 h if no symptoms had developed with the previous administration, in order to reach a cumulative dose of 25mg. All subjects underwent two double-blind, placebo-controlled challenges in two consecutive days. Results: No reactions against placebo were observed. Similarly, no reactions were observed in all subjects both after the first and after the second challenge to rofecoxib. Conclusions: The present study demonstrated that rofecoxib does not have cross-reactivity to NSAIDs. Rofecoxib is a safe alternative in subjects with previous adverse cutaneous reaction to NSAIDs.