Drug-Related Deaths in China: An Analysis of a Spontaneous Reporting System.

ABSTRACT: Background: Adverse drug reactions with an outcome of death represent the most serious consequences and are inherently important for pharmacovigilance. The nature and characteristics of drug-related deaths are to a large extent unknown in the Chinese population. This study aims to characterize drug-related deaths by analysis of individual case safety reports (ICSRs) with an outcome of death in China. Methods: The characteristics of death ICSRs were analyzed by descriptive statistics of a large multi-provincial pharmacovigilance database in China. Results: There were 1,731 ICSRs with an outcome of death, representing 0.95% of all serious cases and 0.05% of all reported ICSRs. Most death ICSRs (78.57%) were reported by medical institutions. Only 16.00% of death ICSRs wer

SUBMITTER: Li H 

PROVIDER: S-EPMC8914085 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature