Safety of etoricoxib in patients with reactions to NSAIDs.

BACKGROUND Adverse reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) are a frequently reported problem due to the fact that these molecules are often used for control of pain and inflammation. Although the use of selective inhibitors of cyclooxygenase (COX) 2 helps to prevent some of these adverse reactions, they can have cardiac side effects when taken for prolonged periods. Here we report the safety and tolerability of etoricoxib, a selective COX-2 inhibitor with fewer cardiovascular effects, in patients with adverse reactions to NSAIDs. PATIENTS AND METHODS We performed placebo-controlled oral challenge with etoricoxib in 65 patients with previous adverse reactions to NSAIDs: 13 to salicylates, 18 to arylpropionic acids, 10 to arylacetic acid, 12 to oxicam and derivates, 8 to pyrazolones, and 4 to acetaminophen (paracetamol). The reported symptoms were urticaria or angioedema in 69%, rhinitis in 3%, and 1 case of anaphylactic shock (1.5%). The challenge was done using the placebo on the first day, half dosage of etoricoxib (45 mg) on the second day, and the therapeutic dose of 90 mg on the third day. The challenge was done in the outpatient department of the hospital and the subjects were monitored for a further 4 to 6 hours after challenge. RESULTS Oral challenge with etoricoxib was well tolerated in 97% of the patients. Only 2 systemic reactions were reported during the challenge test. CONCLUSION Etoricoxib can be considered a safe molecule for those patients with previous adverse reactions to NSAIDs.