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ADVERSE REACTIONS

Adverse Drug Events Involving COX-2 Inhibitors

Drug Information Pharmacist, University of Pittsburgh Medical Center; Instructor, University of Pittsburgh School of Pharmacy, University of Pittsburgh Drug Information Center, Pittsburgh, PA

Robert J Weber, MS FASHP

Executive Director, University of Pittsburgh Medical Center Presbyterian/Shadyside; Department Chairman, Department of Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy

Teresa P McKaveney, BS

Research Assistant, Department of Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy

Nicole T Ansani, PharmD

Associate Director of Drug Information, University of Pittsburgh Medical Center; Assistant Professor of Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy

Adele L Towers, MD MPH

Medical Director, Primary Care and Geriatric Medicine, University of Pittsburgh Medical Center; Assistant Professor of Medicine and Psychiatry, University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh

Reprints: Margaret M Verrico BSPharm, University of Pittsburgh Drug Information Center, 137 Victoria Hall, Pittsburgh, PA 15261-0001, FAX 412/624-6350, verricomm{at}msx.upmc.edu

OBJECTIVE: To describe the types and severity of adverse drug-related events (ADEs) observed in patients receiving cyclooxygenase-2 (COX-2) inhibitors and to increase the awareness of risk factors that predispose patients to ADEs associated with COX-2 inhibitors.

METHODS: A review of ADEs reported at the University of Pittsburgh Medical Center Presbyterian Hospital (UPMC-P) revealed significant events related to use of celecoxib or rofecoxib. A query of the internal ADE database was performed to identify ADEs involving COX-2 inhibitors from January 1999 to June 2002. A similar query was performed to identify ADEs involving nonselective nonsteroidal antiinflammatory drugs (NSAIDs) reported during this same time period. Utilization data were also collected.

RESULTS: Forty-eight ADEs involving 24 patients receiving COX-2 inhibitors were reported and validated via the UPMC-P ADE review process compared with 38 events in 33 patients receiving nonselective NSAIDs. The types of ADEs reported as related to COX-2 inhibitors were similar to those reported in association with nonselective NSAIDs. Forty-two percent of ADEs (n = 20) involving COX-2 inhibitors and 45% of events (n = 17) involving nonselective NSAIDs were classified as severe. All patients receiving COX-2 inhibitors and 91% of patients receiving nonselective NSAIDs exhibited risk factors that increased their risk to experience an ADE; all but 1 of these patients were receiving outpatient COX-2 inhibitor therapy.

CONCLUSIONS: The observed ADEs involving COX-2 inhibitors were similar to those associated with nonselective NSAIDs. Most events may have been preventable, highlighting the need for education regarding the appropriate use of COX-2 inhibitors.

Key Words: adverse reactions, celecoxib, cyclooxygenase-2 inhibitors, drug interactions, rofecoxib

Published Online, July 17, 2003. www.theannals.com, DOI 10.1345/aph.1A212

THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE UNIVERSAL PROGRAM NUMBER: 407-000-03-023-H01

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