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.
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