PMID- 37032639
OWN - NLM
STAT- MEDLINE
DCOM- 20230807
LR  - 20230807
IS  - 1755-5949 (Electronic)
IS  - 1755-5930 (Print)
IS  - 1755-5930 (Linking)
VI  - 29
IP  - 9
DP  - 2023 Sep
TI  - Cardiac adverse events associated with quetiapine: Disproportionality analysis of 
      FDA adverse event reporting system.
PG  - 2705-2716
LID - 10.1111/cns.14215 [doi]
AB  - OBJECTIVE: Quetiapine, an atypical second-generation antipsychotic drug, is 
      approved for treatment of schizophrenia, bipolar disorder, and depression. Due to 
      the limitations of clinical trials, the association between quetiapine and rare 
      cardiac adverse events (AEs) is still unclear. This study is to evaluate 
      quetiapine-associated cardiac AEs through data mining of FDA Adverse Event 
      Reporting System (FAERS). METHODS: Reporting odds ratio (ROR) was used to 
      quantify the signals of quetiapine-related cardiac AEs from the first quarter 
      (Q1) of 2018-2022 Q1. Serious and nonserious cases were compared, and signals 
      were prioritized using a rating scale. RESULTS: A total of 1004 cases of 
      quetiapine-associated cardiac AEs were identified, with 31 signals being 
      detected, among which 13 AEs were identified as new and unexpected signals. 
      Besides, nine and 22 cardiac AEs were identified as moderate and weak clinical 
      priority. The median TTO for moderate and weak clinical priority signals were 0 
      and 4 days, respectively. All of the cardiac AEs had early failure type 
      characteristics, suggesting that most of the patients developed cardiac AEs in a 
      few days after quetiapine treatment, and that the risk of cardiac AEs occurrence 
      would be gradually decreased over time. CONCLUSION: Our study provided valuable 
      evidence for health-care professionals to mitigate the risk of 
      quetiapine-associated cardiac AEs based on an extensive analysis of a real-world, 
      large-sample FAERS database, and prioritize cardiac AE signals.
CI  - (c) 2023 The Authors. CNS Neuroscience & Therapeutics published by John Wiley & 
      Sons Ltd.
FAU - Shu, Yamin
AU  - Shu Y
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
FAU - Ding, Yiling
AU  - Ding Y
AD  - Graduate School of Pharmaceutical Sciences, University of Tokyo, Tokyo, Japan.
FAU - Liu, Lulu
AU  - Liu L
AD  - School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, 
      China.
FAU - Zhang, Qilin
AU  - Zhang Q
AUID- ORCID: 0000-0002-4779-3875
AD  - Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, Wuhan, China.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230410
PL  - England
TA  - CNS Neurosci Ther
JT  - CNS neuroscience & therapeutics
JID - 101473265
RN  - 2S3PL1B6UJ (Quetiapine Fumarate)
RN  - 0 (Antipsychotic Agents)
SB  - IM
MH  - United States/epidemiology
MH  - Humans
MH  - Quetiapine Fumarate/adverse effects
MH  - Adverse Drug Reaction Reporting Systems
MH  - United States Food and Drug Administration
MH  - *Antipsychotic Agents/adverse effects
MH  - *Bipolar Disorder/drug therapy
PMC - PMC10401141
OTO - NOTNLM
OT  - FAERS
OT  - cardiac adverse events
OT  - data mining
OT  - disproportionality analysis
OT  - pharmacovigilance
OT  - quetiapine
COIS- The authors declare that they have no conflicts of interest.
EDAT- 2023/04/11 06:00
MHDA- 2023/08/07 06:42
PMCR- 2023/04/10
CRDT- 2023/04/10 03:32
PHST- 2023/03/21 00:00 [revised]
PHST- 2022/12/27 00:00 [received]
PHST- 2023/03/30 00:00 [accepted]
PHST- 2023/08/07 06:42 [medline]
PHST- 2023/04/11 06:00 [pubmed]
PHST- 2023/04/10 03:32 [entrez]
PHST- 2023/04/10 00:00 [pmc-release]
AID - CNS14215 [pii]
AID - 10.1111/cns.14215 [doi]
PST - ppublish
SO  - CNS Neurosci Ther. 2023 Sep;29(9):2705-2716. doi: 10.1111/cns.14215. Epub 2023 
      Apr 10.