Safety of celecoxib in patients with adverse skin reactions to acetaminophen (paracetamol) and other non-steroidal anti-inflammatory drugs

• Published in: Journal of investigational allergology & clinical immunology Vol. 15; no. 4; p. 249
• Main Authors: Liccardi, G, Cazzola, M, De Giglio, C, Manfredi, D, Piscitelli, E, D'Amato, M, D'Amato, G
• Format: Journal Article
• Language: English
• Published: Spain 2005
• Subjects: Acetaminophen - adverse effects; Adolescent; Adult; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Anti-Inflammatory Agents, Non-Steroidal - pharmacology; Celecoxib; Cyclooxygenase Inhibitors - adverse effects; Cyclooxygenase Inhibitors - pharmacology; Drug Hypersensitivity; Female; Humans; Male; Middle Aged; Pyrazoles - adverse effects; Pyrazoles - pharmacology; Single-Blind Method; Skin Diseases - chemically induced; Sulfonamides - adverse effects; Sulfonamides - pharmacology
• ISSN: 1018-9068

Acetaminophen (paracetamol-P) is a widely used analgesic-antipyretic drug with no anti inflammatory effects and its rate of adverse hypersensitivity reactions is very low. On the contrary non-steroidal anti-inflammatory drugs (NSAIDs) are commonly involved in side effects. Celecoxib (CE) is a novel drug, with high selectivity and affinity for COX-2 enzyme. We evaluated the tolerability of CE in a group of patients with documented history of adverse cutaneous reactions to P and to classic NSAIDs. We studied 29 patients with hypersensitivity to P and classic NSAIDs. The diagnosis of P-induced skin reactions was based on 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 was given. After 2-3 days, a single dose of 200 mg was administered. All patients were observed for 6 hours after each challenge, and they were controlled again after 24 hours to exclude delayed reactions. The challenge was considered positive if one or more of the following appeared: erythema, rash or urticaria-angioedema. No reaction was observed with placebo and twenty eight patients (96.5 %) tolerated CE. Only one patient developed a moderate angioedema of the lips. Only one hypersensitivity reaction to CE was documented among 29 P-intolerant patients. Thus, we conclude that CE is a reasonably safe alternative which can be used in subjects who do not tolerate P.