Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2023 Dec;32(12):1341-1349.
doi: 10.1002/pds.5663. Epub 2023 Jul 12.

Investigation of hepatic adverse events due to quetiapine by using the common data model

SooJeong Ko  1   2 , Se-Hyun Chang  3 , Yeon Woong Chung  1   4 , Young-Gyun Seo  5 , Dong-Yoon Kang  6 , Kwangsoo Kim  7 , Dong-Jin Chang  8 , In Young Choi  1
Affiliations
Observational Study

Investigation of hepatic adverse events due to quetiapine by using the common data model

SooJeong Ko et al. Pharmacoepidemiol Drug Saf. 2023 Dec.

Abstract

Purpose: Quetiapine is a drug used to treat schizophrenia, bipolar disorder, and major depressive disorder. However, it can cause mild or severe hepatic adverse events and rarely fatal liver damage. This study was aimed at investigating hepatic toxicity caused by quetiapine use by analyzing the information captured from hospital electronic health records by using the Observational Medical Outcomes Partnership common data model (CDM).

Methods: This was a retrospective observational study involving a nested case-control method. A CDM based on an electronic health record database from five hospitals between January 2009 and May 2020 was used. We analyzed the status of quetiapine use, adverse events, and hepatic impairment.

Results: The numbers of patients with non-serious and severe hepatic adverse reactions were 2566 (5.05%) and 835 (1.64%) out of 50 766 patients, respectively. After adjusting for covariates, the odds ratio of hepatic adverse events was 2.35 (95% CI: 2.03-2.72), and the odds ratio of severe hepatic adverse events was 1.76 (95% CI: 1.16-2.66).

Conclusion: Our findings suggest that quetiapine should be cautiously used, and hepatic function should be monitored in patients using quetiapine because it can cause mild or severe hepatic adverse events, complications, and in rare cases, fatal liver damage.

Keywords: OMOP CDM; common data model; hepatic adverse events; liver function; quetiapine.

PubMed Disclaimer

References

REFERENCES

    1. Suttajit S, Srisurapanont M, Maneeton N, Maneeton B. Quetiapine for acute bipolar depression: a systematic review and meta-analysis. Drug Des Dev Ther. 2014;8:827-838. doi:10.2147/DDDT.S63779
    1. Garver DL. Review of quetiapine side effects. J Clin Psychiatry. 2000;61(Suppl 8):31-33; discussion 34-35.
    1. Small JG, Hirsch SR, Arvanitis LA, Miller BG, Link CG. Quetiapine in patients with schizophrenia. A high- and low-dose double-blind comparison with placebo. Seroquel Study Group. Arch Gen Psychiatry. 1997;54:549-557. doi:10.1001/archpsyc.1997.01830180067009
    1. Emsley RA, Raniwalla J, Bailey PJ, Jones AM. A comparison of the effects of quetiapine (“Seroquel”) and haloperidol in schizophrenic patients with a history of and a demonstrated, partial response to conventional antipsychotic treatment. PRIZE Study Group. Int Clin Psychopharmacol. 2000;15:121-131. doi:10.1097/00004850-200015030-00001
    1. Copolov DL, Link CG, Kowalcyk B. A multicentre, double-blind, randomized comparison of quetiapine (ICI 204,636, “Seroquel”) and haloperidol in schizophrenia. Psychol Med. 2000;30:95-105. doi:10.1017/s0033291799001476

Publication types

MeSH terms