Tags

Type your tag names separated by a space and hit enter

Investigation of pegloticase-associated adverse events from a nationwide reporting system database.

Abstract

PURPOSE

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).

CONCLUSION

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.

Links

  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    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.

    , , , , ,

    Source

    MeSH

    Adverse Drug Reaction Reporting Systems
    Data Mining
    Humans
    Polyethylene Glycols
    Retrospective Studies
    United States
    Urate Oxidase

    Pub Type(s)

    Journal Article

    Language

    eng

    PubMed ID

    24733135

    Citation

    Gentry, William M., et al. "Investigation of Pegloticase-associated Adverse Events From a Nationwide Reporting System Database." American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists, vol. 71, no. 9, 2014, pp. 722-7.
    Gentry WM, Dotson MP, Williams BS, et al. Investigation of pegloticase-associated adverse events from a nationwide reporting system database. Am J Health Syst Pharm. 2014;71(9):722-7.
    Gentry, W. M., Dotson, M. P., Williams, B. S., Hartley, M., Stafford, K. R., Bottorff, M. B., & Gandhi, P. K. (2014). Investigation of pegloticase-associated adverse events from a nationwide reporting system database. American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists, 71(9), pp. 722-7. doi:10.2146/ajhp130571.
    Gentry WM, et al. Investigation of Pegloticase-associated Adverse Events From a Nationwide Reporting System Database. Am J Health Syst Pharm. 2014 May 1;71(9):722-7. PubMed PMID: 24733135.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Investigation of pegloticase-associated adverse events from a nationwide reporting system database. AU - Gentry,William M, AU - Dotson,Michael P, AU - Williams,Brian S, AU - Hartley,Melissa, AU - Stafford,Kristen R, AU - Bottorff,Michael B, AU - Gandhi,Pranav K, PY - 2014/4/16/entrez PY - 2014/4/16/pubmed PY - 2014/12/17/medline SP - 722 EP - 7 JF - American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists JO - Am J Health Syst Pharm VL - 71 IS - 9 N2 - PURPOSE: 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). CONCLUSION: 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. SN - 1535-2900 UR - https://www.unboundmedicine.com/medline/citation/24733135/full_citation L2 - https://academic.oup.com/ajhp/article-lookup/doi/10.2146/ajhp130571 DB - PRIME DP - Unbound Medicine ER -