Evidence map›Paper›PMID 39215339›Full record

ArticleBMC pharmacology & toxicology2024

Drug-induced liver injury associated with atypical generation antipsychotics from the FDA Adverse Event Reporting System (FAERS).

Sidi He, Bin Chen, Chuanwei Li

Abstract read
In one paragraph

Article in BMC pharmacology & toxicology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Pharmacovigilance study and development of a clinical decision flowchart for personalized selection of trastuzumab, T-DXd, and T-DM1 in breast cancer patients.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Sidi HeSuzhou Guangji Hospital, Affiliated Guangji Hospital of Soochow University, Suzhou, Jiangsu Province, 215008, China.
Bin ChenDepartment of Orthopedics, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Chuanwei LiSuzhou Guangji Hospital, Affiliated Guangji Hospital of Soochow University, Suzhou, Jiangsu Province, 215008, China. avylee@163.com.

Funding

The Scientific and Technological Program of Suzhou SKY2021064
6 · The paper itself

Abstract

backgroundRecent studies have shown that liver enzyme abnormalities were not only seen with typical antipsychotics (APs) but also with atypical antipsychotics (AAPs). During the last 20 years, the hepatotoxicity of various antipsychotics received much attention. However, systematic evaluations of hepatotoxicity associated with APs are limited.

methodsAll drug related hepatic disorders cases were retrieved from the FDA Adverse Event Reporting System (FAERS) database using standardized MedDRA queries (SMQ) from the first quarter of 2017 to the first quarter of 2022. Patient characteristics and prognosis were assessed. In this study, a case/non-case approach was used to calculate reporting odds ratio (RORs) and 95% confidence intervals (CIs). We calculated the drug-induced liver injury (DILI) RORs for each AAPs.

resultsA total of 408 DILI cases were attributed to AAPs during the study period. 18.6% of these were designated as serious adverse event (SAE), which include death (19.74%), hospitalization (68.42%), disability (2.63%), and life-threatening (9.21%) outcomes. The RORs values in descending order were: quetiapine (ROR = 0.782), clozapine (ROR = 0.665), aripiprazole (ROR = 0.507), amisulpride (ROR = 0.308), paliperidone (ROR = 0.212), risperidone (ROR = 0.198), ziprasidone (0.131).

conclusionThe result found in our study was that all AAPs didn't have a significant correlation with increased hepatotoxicity. Future analysis of the FAERS database in conjunction with other data sources will be essential for continuous monitoring of DILI.

Indexed as

Adverse Drug Reaction Reporting SystemsAntipsychotic AgentsChemical and Drug Induced Liver InjuryUnited States Food and Drug AdministrationAdolescentAdultAgedDatabases, FactualFemaleHumansMaleMiddle AgedUnited StatesYoung AdultAntipsychotic AgentsAAPsDILIFAERSHepatotoxicityReporting odds ratio (RORs)SAE

Identifiers

PMID39215339
PMCPMC11363531

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.