Safety of celecoxib in patients with adverse skin reactions to acetaminophen (paracetamol) and nimesulide associated or not with common non-steroidal anti-inflammatory drugs.
BACKGROUND
Acetaminophen (paracetamol--P) and Nimesulide (N) are widely used analgesic-antipyretic/anti-inflammatory drugs. The rate of adverse hypersensitivity reactions to these agents is generally low. On the contrary non-steroidal anti-inflammatory drugs (NSAIDs) are commonly involved in such reactions. Celecoxib (CE) is a novel drug, with high selectivity and affinity for COX-2 enzyme.


OBJECTIVE
We evaluated the tolerability of CE in a group of patients with documented history of adverse cutaneous reactions to P and N associated or not to classic NSAIDs.


METHODS
We studied 9 patients with hypersensitivity to P and N with or without associated reactions to classic NSAIDs. The diagnosis of P and N-induced skin reactions was based in vivo challenge. The placebo was blindly administered at the beginning of each challenge. After three days, a cumulative dosage of 200 mg of CE in refracted doses were given. After 2-3 days, a single dose of 200 mg was administered. All patients were observed for 6 hours after each challenge, and controlled again after 24 hours to exclude delayed reactions. The challenge was considered positive if one or more of the following appeared: erythema, rush or urticaria-angioedema.


RESULTS
No reaction was observed with placebo and eight patients (88.8%) tolerated CE. Only one patient developed a moderate angioedema of the lips.


CONCLUSIONS
Only one hypersensitivity reaction to CE was documented among 9 P and N-highly NSAIDs intolerant patients. Thus, we conclude that CE is a reasonably safe alternative to be used in subjects who do not tolerate P and N.
Liccardi
Gennaro
G
Department of Chest Diseases, Division of Pneumology and Allergology A. Cardarelli, Hospital Naples, Italy.
Salzillo
Antonello
A
Piccolo
Amedeo
A
Senna
Gianenrico
G
Piscitelli
Eugenia
E
D'Amato
Maria
M
D'Amato
Gennaro
G
D000082:Acetaminophen / Q000009:adverse effects*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000799:Angioedema / Q000139:chemically induced; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects* / Q000494:pharmacology; D000068579:Celecoxib; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects* / Q000494:pharmacology; D004306:Dose-Response Relationship, Immunologic; D004338:Drug Combinations; D003875:Drug Eruptions / Q000209:etiology; D004342:Drug Hypersensitivity / Q000175:diagnosis / Q000209:etiology*; D005260:Female; D006801:Humans; D006969:Hypersensitivity, Immediate / Q000150:complications; D008297:Male; D008875:Middle Aged; D011720:Pyrazoles / Q000009:adverse effects* / Q000494:pharmacology; D016037:Single-Blind Method; D012882:Skin Tests; D013449:Sulfonamides / Q000009:adverse effects* / Q000494:pharmacology
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D004338:Drug Combinations; D011720:Pyrazoles; D013449:Sulfonamides; D000082:Acetaminophen; D000068579:Celecoxib; C012655:nimesulide