Tolerability of rofecoxib in patients with cutaneous adverse reactions to nonsteroidal anti-inflammatory drugs.

Background: Adverse reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) are very common problems in clinical practice. Rofecoxib is a novel NSAID which selectively inhibits prostaglandin endoperoxide H synthase-2 and has no effect on prostaglandin endoperoxide H synthase-1.

Objective: To evaluate the tolerability of rofecoxib in NSAID-sensitive patients with cutaneous adverse reactions.

Patients And Methods: One hundred thirty-nine patients with NSAID-induced adverse reactions [60 urticaria alone (43.1%), 34 angioedema (24.5%), 34 angioedema plus urticaria (24.5%), 5 urticaria plus difficulty in breathing (3.6%), 4 maculopapular rush (2.9%), and 2 Stevens-Johnson syndrome (1.4%)] were submitted to a single-blind, placebo-controlled peroral challenge with increasing doses of rofecoxib.

Results: One hundred thirty-eight of 139 (99.3%) patients tolerated rofecoxib without adverse reactions; only one (0.7%) experienced weak urticaria localized at arms.

Conclusions: Rofecoxib is a well tolerated drug in patients with NSAID cutaneous adverse reactions and it may represent a valid alternative drug in NSAID-sensitive patients.