Signal mining of adverse event risk of limaprost based on US FDA Public Data Open Project platform
10.3760/cma.j.cn114015-20231117-00814
- VernacularTitle:基于美国FDA公共数据开放项目平台的利马前列素不良事件风险信号挖掘
- Author:
Bing LI
1
;
Li LIANG
;
Yan CHEN
;
Yuhang GUO
;
Xia LIU
;
Qiang FU
;
Jinmin GUO
Author Information
1. 中国人民解放军联勤保障部队第九六〇医院临床药学科，济南 250031
- Publication Type:Journal Article
- Keywords:
Spinal stenosis;
Prostaglandins E;
Adverse event risk signal;
Data mining;
Limaroprost
- From:
Adverse Drug Reactions Journal
2024;26(7):417-422
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To mine the risk signals of adverse events of limaprost and provide reference for safe use of the drug.Methods:US FDA Public Data Open Project (OpenFDA) platform was searched, and the adverse event (AE) reports on limaprost from January 1, 2004 to October 1, 2023 were collected. AEs were classified and standardized according to the system organ class (SOC) and preferred terms (PT) of Medical Dictionary for Regulatory Activities version 25.1. The reporting odds ratio (ROR) method was used to mine the risk signal of limaprost. An AE with reports ≥3, ROR ≥2 and the lower limit of the 95% confidence interval ( CI)>1 was defined as a risk signal, which was analyzed descriptively. Results:A total of 1 618 AE reports with limaprost as the primary suspect drug were collected, 69 risk signals were identified, involving 17 SOCs. Of the 69 PTs, 10 were recorded in the drug instructions including hepatic function abnormal, red blood cell count decreased, drug eruption, blood pressure decreased, liver disorder, platelet count decreased, anaemia, haemoglobin decreased, pyrexia, and decreased appetite. The other 59 risk signals were not recorded in the drug instructions. The top 10 PTs in signal intensity were scleroderma, tumour haemorrhage, brain natriuretic peptide increased, inappropriate antidiuretic hormone secretion, colitis microscopic, large intestine perforation, cardiac failure acute, depressive symptom, cardiac failure chronic, pulmonary alveolar haemorrhage. The risk signals with more than 10 reports were inappropriate antidiuretic hormone secretion, interstitial lung disease, renal impairment, cardiac failure, pneumonia, fall, etc.Conclusion:In addition to the AEs recorded in the instructions, limaprost may also cause serious adverse reactions such as tumour haemorrhage, brain natriuretic peptide increased, and inappropriate antidiuretic hormone secretion, which are not recorded in the instructions and have a poor prognosis.
