Adverse Drug Events Involving COX-2 Inhibitors

• Published in: The Annals of pharmacotherapy Vol. 37; no. 9; p. 1203
• Main Authors: Verrico, Margaret M, Weber, Robert J, McKaveney, Teresa P, Ansani, Nicole T, Towers, Adele L
• Format: Journal Article
• Language: English
• Published: United States 01.09.2003
• Subjects: Adult; Adverse Drug Reaction Reporting Systems - statistics & numerical data; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal - adverse effects; Celecoxib; Cyclooxygenase 2; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors - adverse effects; Drug Hypersensitivity - etiology; Drug Interactions; Gastrointestinal Diseases - chemically induced; Heart Diseases - chemically induced; Hospitalization; Humans; International Normalized Ratio; Isoenzymes - antagonists & inhibitors; Kidney Diseases - chemically induced; Lactones - adverse effects; Membrane Proteins; Middle Aged; Prostaglandin-Endoperoxide Synthases; Pyrazoles; Risk Factors; Sulfonamides - adverse effects; Sulfones
• ISSN: 1060-0280
• DOI: 10.1345/aph.1A212

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. 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. 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. 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.