Affiliations 

  • 1 National Pharmaceutical Regulatory Agency, Ministry of Health, Malaysia, Lot 36, Jalan Universiti, 46200, Petaling Jaya, Selangor, Malaysia
  • 2 National Pharmaceutical Regulatory Agency, Ministry of Health, Malaysia, Lot 36, Jalan Universiti, 46200, Petaling Jaya, Selangor, Malaysia. vidhya@npra.gov.my
Ther Innov Regul Sci, 2021 05;55(3):514-522.
PMID: 33393015 DOI: 10.1007/s43441-020-00245-w

Abstract

INTRODUCTION: Allopurinol-induced severe cutaneous adverse drug reactions (SCARs) are potentially debilitating and life-threatening reactions, which can cause a financial burden to the healthcare system.

OBJECTIVES: We aimed to identify risk factors for allopurinol-induced SCARs and to assess their impact on fatality.

METHODS: Adverse drug reaction (ADR) reports with allopurinol as suspected drug were extracted from the Malaysian pharmacovigilance database from year 2000 to 2018. Multiple logistic regression analysis was used to identify significant predictors of allopurinol-induced SCARs. We further analysed the association between covariates and SCARs-related fatality in a separate model. Level of significance was set at p value 

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.