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Allopurinol-induced severe cutaneous adverse drug reactions: Risk minimization measures in Malaysia

Rema Panickar1,2, Wee Kee Wo1, Norleen M Ali1

  • 1National Pharmaceutical Regulatory Agency, Ministry of Health, Petaling Jaya, Malaysia.

Pharmacoepidemiology and Drug Safety
|October 21, 2020
PubMed
Abstract

Insights

Risk minimization measures (RMMs) for allopurinol in Malaysia reduced off-label use adverse drug reactions (ADRs). Further patient education and pharmacogenetic screening are needed to decrease allopurinol-induced severe cutaneous adverse drug reactions (SCARs).

Area of Science:

  • Pharmacovigilance
  • Drug Safety
  • Clinical Pharmacology

Background:

  • Allopurinol is a common medication for gout and hyperuricemia.
  • Severe cutaneous adverse drug reactions (SCARs) are serious side effects of allopurinol.
  • Risk minimization measures (RMMs) are crucial for managing drug-induced adverse events.

Purpose of the Study:

  • To document RMMs for allopurinol-induced SCARs in Malaysia.
  • To evaluate the real-world impact of these RMMs on allopurinol usage and adverse drug reaction (ADR) reports.

Main Methods:

  • Extracted allopurinol ADR reports (2000-2018) from the Malaysian ADR database.
  • Identified RMMs implemented between 2000-2018.
  • Analyzed allopurinol utilization data (2004-2018).
  • Used Pearson chi-squared test to assess the impact of RMMs on ADR reporting.

Main Results:

  • Sixteen RMMs were implemented, including risk communications and educational materials.
  • Allopurinol utilization decreased by 21.5% from 2004 to 2018.
  • ADR reporting rates increased overall, but reports involving off-label use decreased by 6% after 2011.
  • RMMs showed a statistically significant reduction in ADR reports involving off-label use in August 2014 and October 2016.

Conclusions:

  • RMMs promoting appropriate allopurinol use and prescriber education positively impacted ADR reporting.
  • Further measures, including patient education and pharmacogenetic screening, are necessary to reduce allopurinol-induced SCARs incidence and severity.
Keywords:
drug utilizationgouthypersensitivityoff-label usepharmacoepidemiologyrisk management

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