Background: Intolerance to acetylsalicylic acid (ASA) and nonsteroidal anti-inflammatory drugs (NSAIDs) is a crucial problem in medical practice. There is therefore a need for safer NSAIDs in analgesicintolerant patients.

Objective: To assess the safety of rofecoxib, a selective COX-2 inhibitor, in ASA/NSAID-intolerant patients.

Methods: A single blind, placebo-controlled oral challenge procedure was applied to 94 adult patients (M/F: 30/64, mean age: 39.2 ± 11.9 yrs) with a reliable history of ASA/NSAID intolerance. 1/4 and 3/4 divided doses of placebo and rofecoxib were given with 2-hour intervals on consecutive days. During the challenge procedure, blood pressure, heart rate, nasoocular, pulmonary and cutaneous symptoms were monitored. Erythema, pruritus accompanied by erythema, urticaria/angioedema, rhinorrea, nasal obstruction, sneezing, dyspnea or cough associated with a decrease of at least 20% in the FEV1, and hypotension were considered as positive reactions.

Results: None of the patients reacted to placebo. Only one patient (1.1%) presented urticarial-type cutaneous reaction to rofecoxib challenge. The remaining patients (98.9%) perfectly tolerated the drug challenge.

Conclusion: Rofecoxib can be used as a safe alternative drug for ASA/NSAID intolerant patients.

Key words: Aspirin intolerance, asthma, rofecoxib, urticaria, anaphylactoid reaction