Investigation of pegloticase-associated adverse events from a nationwide reporting system database.
PURPOSEPegloticase-associated adverse events reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) database in the United States were evaluated.
METHODSRetrospective data-mining analysis of FAERS case reports listing Krystexxa or pegloticase as the suspect drug and specific adverse events (cardiovascular events, infusion-related reactions, gout flares, and anaphylaxis) was conducted from the drug's approval date (September 14, 2010) through August 27, 2012. Initial and follow-up reports with the same primary linked identification number were identified as unique to each patient case. When multiple reports for the same patient were identified with a common case number, the report with the most recent date was used to eliminate duplicate reports. Bayesian confidence propagation neural network methodology was used to identify signals of drug-associated adverse events. A potential signal for drug-adverse event reports is generated when the lower limit of the 95% two-sided confidence interval of the information component is greater than 0.
RESULTSA total of 118 unique cases of adverse events involving pegloticase in the United States were identified during the study period. Fourteen reports were related to pegloticase-associated cardiovascular events, and 35 were related to pegloticase-associated infusion-related reactions. Twenty-six reports were related to pegloticase-associated gout, and 11 were reports of pegloticase-associated anaphylaxis. Bayesian statistics identified potential signals for all pegloticase-associated adverse events (cardiovascular events, infusion reactions, gout flares, and anaphylaxis).
CONCLUSIONAnalysis of pegloticase-associated adverse events submitted to the FAERS database found that cardiovascular events, infusion-related reactions, gout flares, and anaphylaxis occurred more frequently than was statistically expected.
William M. Gentry, Pharm.D., is Assistant Professor and Executive Associate Dean; Michael P. Dotson is Pharm.D. candidate; Brian S. Williams is Pharm.D. candidate; Melissa Hartley is Pharm.D. candidate; Kristen R. Stafford is Pharm.D. candidate; Michael B. Bottorff, Pharm.D., FCCP, CLS, is Professor and Chair of Pharmacy Practice; and Pranav K. Gandhi, Ph.D., is Assistant Professor, Department of Pharmacy Practice, School of Pharmacy, South College, Knoxville, TN., , , , ,
MeSHAdverse Drug Reaction Reporting Systems
Pub Type(s)Journal Article