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.


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.
Nettis
Eustachio
E
Department of Clinical Immunology and Allergology, University of Bari, Italy. e.nettis@allergy.uniba.it
Di
Paola Roberto
PR
Ferrannini
Antonio
A
Tursi
Alfredo
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D051545:Cyclooxygenase 1; 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; D011451:Prostaglandin-Endoperoxide Synthases; D012871:Skin Diseases / Q000139:chemically induced*; D012882:Skin Tests; D013450:Sulfones
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007527:Isoenzymes; D007783:Lactones; D008565:Membrane Proteins; D013450:Sulfones; C116926:rofecoxib; D051545:Cyclooxygenase 1; C496511:PTGS1 protein, human; D011451:Prostaglandin-Endoperoxide Synthases