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


CONCLUSIONS
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.
Quiralte
Joaquín
J
Allergy Unit, Hospital Universitario Ciudad de Jaén, Spain. jqe01j@saludalia.com
Sáenz de San Pedro
Blanca
B
Florido
J José Fernando
JJ
D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D051546:Cyclooxygenase 2; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects*; D004342:Drug Hypersensitivity / Q000209:etiology*; D005260:Female; D006801:Humans; D007527:Isoenzymes / Q000037:antagonists & inhibitors*; D007783:Lactones / Q000009:adverse effects*; D008297:Male; D008565:Membrane Proteins; D008875:Middle Aged; D011446:Prospective Studies; D011451:Prostaglandin-Endoperoxide Synthases; D016037:Single-Blind Method; D012871:Skin Diseases / Q000139:chemically induced*; D013450:Sulfones
D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D016861:Cyclooxygenase Inhibitors; D007527:Isoenzymes; D007783:Lactones; D008565:Membrane Proteins; D013450:Sulfones; C116926:rofecoxib; D051546:Cyclooxygenase 2; C496540:PTGS2 protein, human; D011451:Prostaglandin-Endoperoxide Synthases