Tolerability of rofecoxib in patients with adverse reactions to nonsteroidal anti-inflammatory drugs: A study of 216 patients and literature review

Maria Rosaria Perrone, Maria Cristina Artesani, Marinella Viola, Francesco Gaeta, Mario Caringi, Donato Quaratino, Antonino Romano

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Adverse reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) are frequent, particularly among patients with chronic urticaria or asthma. The identification of an alternative safe and reliable drug is a common problem in clinical practice. Objective: To assess the tolerability of rofecoxib, a new NSAID that selectively inhibits the inducible isoform of cyclooxygenase, in a large group of NSAID-sensitive patients. Methods: We studied 216 patients (164 females and 52 males) who had suffered adverse reactions to one or more NSAIDs; 98 subjects (45.4%) had experienced reactions to only one NSAID (single hypersensitivity) and 118 subjects (54.6%) had reacted to multiple NSAIDs (multiple hypersensitivity). Cutaneous reactions were reported by 79.6% of the subjects, respiratory symptoms by 10.7%, cutaneous and respiratory symptoms by 8.3%, anaphylaxis by 1.4%. All the subjects underwent a single-blind, placebo-controlled oral challenge with divided therapeutic doses of rofecoxib (6.25 mg + 18.75 mg 1 h later = cumulative dose of 25 mg). Results: No reactions to the placebo were observed; only 1 subject (0.46%) experienced an urticarial reaction, after the second dose of rofecoxib. Conclusions: Considering previous studies and our own data, rofecoxib was well tolerated by all of the 174 patients with exclusively NSAID-related respiratory symptoms. Rofecoxib also had a very low rate (1.6%) of cross-reactivity in the 600 patients with exclusively cutaneous reactions to NSAIDs.

Original languageEnglish
Pages (from-to)82-86
Number of pages5
JournalInternational Archives of Allergy and Immunology
Volume132
Issue number1
DOIs
Publication statusPublished - 2003

Keywords

  • Challenges
  • Hypersensitivity
  • Nonsteroidal anti-inflammatory drugs
  • Rofecoxib

ASJC Scopus subject areas

  • Immunology
  • Immunology and Allergy

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