Analysis of adverse events signaling of lurasidone by Open Vigil FDA2.1
10.13699/j.cnki.1001-6821.2024.17.023
- VernacularTitle:用Open Vigil FDA2.1对鲁拉西酮不良事件信号的分析
- Author:
Yu-Qing CHEN
1
;
Zhan-Zhang WANG
;
Xiu-Qing ZHU
;
Ye YANG
;
Li-Jing DAI
;
Hao-Yang LU
;
E-Mei SONG
;
Yu-Guan WEN
Author Information
1. 广州医科大学附属脑科医院Ⅰ期临床研究室,广东广州 510370
- Keywords:
lurasidone;
adverse event;
data mining;
proportional imbalance measurement;
U.S.Food and Drug Administration Adverse Event Reporting System
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(17):2567-2571
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the occurrence of adverse events of lurasidone in the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database by using Open Vigil FDA2.1,to enrich the experience and provide the basis for the clinical use of the drug in China.Methods Using Open Vigil FDA2.1,adverse event data were extracted from the FAERS database for a total of 51 quarters from the 4th quarter of 2010 to the 3rd quarter of 2023,and the ratio of reporting ratio(ROR)method and the proportional reporting ratio(PRR)method were used for data mining and analysis.Results A total of 32 728 adverse event reports with lurasidone as the first suspected drug was obtained,with a larger proportion of females(54.26％)and occurring mostly in adults(18 to 59 years).After the screening,326 preferred term(PT)signals were obtained,involving 20 system-organ classifications(injury,poisoning and procedural complications,general disorders and administration site conditions,psychiatric disorders,etc.).Among them,PTs with the higher frequency of occurrence included off label use,feeling abnormal,crying,anxiety,depression,insomnia,etc.PTs with stronger signal strength included activation syndrome,mania,tongue movement disturbance,hypoprolactinaemia,akathisia,etc.Multiple new suspected adverse drug reactions were unearthed,including hypoprolactinaemia,emotional poverty,stiff tongue,etc.Conclusion Lurasidone has a favorable safety profile,and women need to closely monitor prolactin levels when taking this medication.The drug is relatively safe for use in pregnant,puerperal and perinatal women and patients with poor metabolic function.Hypoprolactinaemia and restless leg syndrome are new rare suspected adverse events with lurasidone.
