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Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
Published on: January 31, 2022
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Aripiprazole-induced liver injury: a spontaneous reporting database study
Yunjuan Gao1,2, Chengzhao Wu1,2, Xingran Zhai2
1School of Pharmacy, Chengdu University of Traditional Chinese Medicine, Chengdu, China.
Frontiers in Pharmacology
|September 11, 2023
Summary
Aripiprazole use can cause drug-induced liver injury (DILI), particularly in young adults, often within 15-90 days of continuous use. Healthcare professionals should monitor liver function closely in patients with risk factors.
Area of Science:
- Pharmacovigilance
- Hepatology
- Clinical Pharmacology
Background:
- Individual case reports of aripiprazole-induced liver injury (DILI) exist, but comprehensive analysis of spontaneous reports is lacking.
- This study addresses the need for a systematic evaluation of DILI characteristics associated with aripiprazole.
Purpose of the Study:
- To analyze the clinical characteristics and risk factors of DILI associated with aripiprazole using spontaneous adverse event reports.
- To enhance understanding of aripiprazole's liver safety profile.
Main Methods:
- Retrospective analysis of 452 aripiprazole-induced liver injury reports from the China Adverse Drug Reaction Monitoring System (2012-2016).
- Evaluation of patient demographics, clinical features, onset time, and co-administered medications.
Main Results:
- 121 (26.8%) of 452 DILI cases were serious.
- The average age was 34.56 years, with a high proportion of young adults; onset typically occurred within 15-90 days.
- Off-label use, higher-than-recommended dosages, and concomitant medications potentially causing liver injury were noted in some cases.
Conclusions:
- Aripiprazole can cause DILI, with a significant proportion of serious events observed.
- Early and regular liver function monitoring is crucial for patients with potential risk factors to mitigate adverse reactions.

