The safety of celecoxib in patients with aspirin-sensitive asthma.
OBJECTIVE
To determine whether celecoxib, a selective cyclooxygenase 2 (COX-2) inhibitor, cross-reacts in patients with aspirin-exacerbated respiratory disease (AERD) with asthma.


METHODS
Sixty patients with asthma underwent double-blinded, placebo-controlled oral challenges with celecoxib (100 mg, 200 mg, and 2 placebos) over 48 hours in our General Clinical Research Center. The next day, sensitivity to acetylsalicylic acid (ASA) was proven in all patients with the use of single-blinded ASA challenges.


RESULTS
None of the 60 patients experienced any symptoms, changes in nasal examinations, or declines in forced expiratory volume in 1 second during the celecoxib challenges. All 60 patients experienced oculonasal and/or asthmatic reactions to ASA, with a mean provoking dose of 69 mg. The exact 1-sided confidence interval for the probability of celecoxib inducing cross-reactions in AERD patients was calculated to be between 0% and 5%.


CONCLUSIONS
Cross-reactivity between ASA and celecoxib does not occur in patients with AERD. These results do not preclude the possibility of other types of immune reactions occurring with celecoxib after prior exposure. Our results add to the growing body of evidence that inhibition of COX-1 is a critical initiating event in the precipitation of respiratory reactions in AERD patients following ingestion of nonsteroidal antiinflammatory drugs.
Woessner
Katharine M
KM
Scripps Clinic and the Scripps Research Institute, La Jolla, California 92037, USA. woessner@scripps.edu
Simon
Ronald A
RA
Stevenson
Donald D
DD
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D001241:Aspirin / Q000009:adverse effects*; D001249:Asthma / Q000139:chemically induced*; D000068579:Celecoxib; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004342:Drug Hypersensitivity / Q000209:etiology; D004357:Drug Synergism; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011720:Pyrazoles; D013449:Sulfonamides / Q000009:adverse effects*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib; D001241:Aspirin