Short-term and long-term tolerability of rofecoxib in patients with prior reactions to nonsteroidal anti-inflammatory drugs.
BACKGROUND
Rofecoxib is a selective cyclooxygenase 2 (COX-2) inhibitor and is well tolerated as an alternative to nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with a previous adverse reaction to other classes of NSAIDs. Until now, there has not been information in the literature about its long-term tolerability.


OBJECTIVE
To provide follow-up data on patients with a history of adverse cutaneous reactions to NSAIDs who underwent and tolerated a challenge test with rofecoxib.


METHODS
Study patients had historically experienced cutaneous adverse reactions to aspirin and NSAIDs and had undergone single-blind challenges with rofecoxib, 25 mg. A questionnaire was distributed to all participants. In particular, they were asked to clarify any reactive symptoms they had developed after ingestion of the drug. All patients were reexamined 1 to 3 years after testing. At reexamination, they were carefully and personally interviewed using the previously distributed questionnaire.


RESULTS
Of the 182 patients who participated in the study, none reacted to rofecoxib during single-blind challenges. Fifty-one (28%) never received rofecoxib again, whereas 131 (72%) were exposed to rofecoxib, often on multiple occasions. Only 7 (5%) of the 131 patients reported cutaneous reactions to rofecoxib during the 3 years of follow-up.


CONCLUSIONS
Rofecoxib appears to be a safe alternative drug among atopic individuals, antibiotic-hypersensitive individuals, and individuals who experienced adverse cutaneous reactions to more than 1 class of NSAIDs, but it is less safe among chronic urticaria patients. Further investigations that include a larger sample are required to confirm our results especially among chronic urticaria patients.
Nettis
Eustachio
E
Department of Medical Clinic, Immunology and Infectious Diseases, Division of Allergy and Clinical Immunology, University of Bari, Bari, Italy. e.nettis@allergy.uniba.it
Colanardi
Maria Cristina
MC
Ferrannini
Antonio
A
Tursi
Alfredo
A
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D001249:Asthma / Q000188:drug therapy*; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D004342:Drug Hypersensitivity / Q000209:etiology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007407:Interviews as Topic; D007783:Lactones / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016037:Single-Blind Method; D013450:Sulfones / Q000009:adverse effects* / Q000627:therapeutic use; D014581:Urticaria / Q000139:chemically induced
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016861:Cyclooxygenase Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib