Hepatic adverse drug reactions in Malaysia: An 18-year review of the national centralized reporting system

Lee FY 1 , Wong HS 1 , Chan HK 2 , Mohamed Ali N 3 , Abu Hassan MR 2 , Omar H 4 Show all authors , Abdul Mutalib NA 4

Affiliations 

  • 1 Clinical Research Centre, Selayang Hospital, Ministry of Health Malaysia, Batu Caves, Selangor, Malaysia
  • 2 Clinical Research Centre, Sultanah Bahiyah Hospital, Ministry of Health Malaysia, Alor Setar, Kedah, Malaysia
  • 3 Pharmacovigilance Section, Center For Post-Registration and Cosmetic Control, National Pharmaceutical Regulatory Agency (NPRA), Petaling Jaya, Selangor, Malaysia
  • 4 Hepatology Department, Selayang Hospital, Ministry of Health Malaysia, Batu Caves, Selangor, Malaysia
Pharmacoepidemiol Drug Saf, 2020 12;29(12):1669-1679.
PMID: 33064335 DOI: 10.1002/pds.5153

Abstract

PURPOSE: To determine the incidence, demographic profile, background of reporters, causative agents, severity and clinical outcomes of hepatic adverse drug reaction (ADR) reports in Malaysia using the national ADR reporting database.

METHODS: The ADR reports recorded between 2000 and 2017 were retrospectively analysed to identify hepatic ADR reports. The trend and characteristics of hepatic ADR cases were described. Multivariate disproportionality analysis of the causative agents was performed to generate signals of hepatic ADRs.

RESULTS: A total of 2090 hepatic ADRs (1.77% of all ADRs) were reported with mortality rate of 12.7% among cases with known clinical outcomes. The incidence of hepatic ADR reporting in Malaysia increased significantly over 18 years from 0.26 to 9.45 per million population (P 

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

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