title: Investigation of pegloticase-associated adverse events from a nationwide reporting system database.
abstract: OBJECTIVE
  Pegloticase-associated adverse events reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) database in the United States were evaluated.
  
  
  METHODS
  Retrospective 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.
  
  
  RESULTS
  A 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).
  
  
  CONCLUSIONS
  Analysis 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.
authors.affiliation: 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.
authors.forename: William M
authors.initials: WM
authors.lastname: Gentry
authors.forename: Michael P
authors.initials: MP
authors.lastname: Dotson
authors.forename: Brian S
authors.initials: BS
authors.lastname: Williams
authors.forename: Melissa
authors.initials: M
authors.lastname: Hartley
authors.forename: Kristen R
authors.initials: KR
authors.lastname: Stafford
authors.forename: Michael B
authors.initials: MB
authors.lastname: Bottorff
authors.forename: Pranav K
authors.initials: PK
authors.lastname: Gandhi
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D057225:Data Mining; D006801:Humans; D011092:Polyethylene Glycols / Q000009:adverse effects*; D012189:Retrospective Studies; D014481:United States; D014503:Urate Oxidase / Q000009:adverse effects*
chemical_list: D011092:Polyethylene Glycols; D014503:Urate Oxidase; C031545:Pegloticase