Data mining of risk signals for linaclotide based on FAERS database
- VernacularTitle:基于FAERS数据库的利那洛肽风险信号挖掘
- Author:
Ke ZHANG
1
;
Bo LI
1
;
Yin SONG
1
;
Xuan SUN
1
;
Jia SHAO
2
;
Zhengxiang LI
1
Author Information
1. Dept. of Pharmacy，Tianjin Medical University General Hospital，Tianjin 300052，China
2. Dept. of Pharmacy，Tianjin First Central Hospital，Tianjin 300192，China
- Publication Type:Journal Article
- Keywords:
linaclotide;
FDA adverse event reporting system;
risk signal;
reporting odds ratio;
proportional report ratio
- From:
China Pharmacy
2022;33(22):2758-2761
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To mine the risk signals of linaclotide， so as to provide evidence for clinically safe drug use. METHODS OpenVigil 2.1 data platform was used to obtain the adverse drug event （ADE） report data of linaclotide from August 30， 2012 to December 31， 2021 in the database of FDA adverse event reporting system （FAERS）. The reporting odds ratio （ROR） and proportional report ratio （PRR） of the proportional imbalance method were used to mine the data of ADE reports. The mined risk signals were statistically classified and described by the preferred system organ class （SOC） and preferred term （PT） stated in the Medical Dictionary for Regulatory Activities （23.1 edition）. RESULTS There were 17 590 ADE reports related to linaclotide， including 5 494 reports of severe ADE， accounting for about 31.23%. A total of 120 risk signals were detected. According to the frequency of occurrence， top 10 risk signals （measured by PT） were diarrhea， ineffective drugs， off-label drug use， abdominal distension， abdominal pain， improper administration time， epigastric pain， flatulence， product storage error and intentional misuse of products. According to the signal intensity， the increase of dihydrotestosterone （ROR was 271.258， PRR was 271.131） ranked the first， and two signals such as the increase of dihydrotestosterone and the compression of intervertebral disc were not mentioned in the drug instructions. The SOC of risk signals obtained by two sorting methods mainly included various examinations， gastrointestinal diseases， systemic diseases and various reactions at the administration site. CONCLUSIONS In clinical application of linaclotide， in addition to the adverse drug reactions mentioned in the drug instructions， close attention should be paid to safety risks such as increase of dihydrotestosterone and the compression of intervertebral disc， which are not mentioned in the instructions， so as to guarantee the safety of drug use.
