Risk signal mining of tafamidis based on US FDA Adverse Event Reporting System
10.3760/cma.j.cn114015-20220324-00238-1
- VernacularTitle:基于美国FDA不良事件报告系统数据库的氯苯唑酸风险信号挖掘
- Author:
Yan CHEN
1
;
Yuhang GUO
1
;
Jinmin GUO
1
Author Information
1. 中国人解放军联勤保障部队第九六〇医院临床药学科，济南 250000
- Publication Type:Journal Article
- Keywords:
Adverse drug reaction reporting system;
Transthyretin amyloid cardiomyopathy;
Data analysis;
Tafamidis
- From:
Adverse Drug Reactions Journal
2023;25(6):352-358
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To mine risk signals related to tafamidis, which was a rare disease drug and newly included in the medical insurance list.Methods:The drug-related adverse event (AE) reports from the 1st quarter of 2013 to the 2nd quarter of 2022 were searched based on the US FDA Adverse Event Reporting System and AE reports with tafamidis as the primary suspect drug were extracted. The report odds ratio ( ROR) method and Bayesian confidence propagation neural network (BCPNN) method were used to detect the AE risk signals of tafamidis. A target AE with reports ≥3 and 95% confidence interval ( CI) lower limit of ROR>1 was defined as a positive signal for ROR method and the larger the ROR and its lower limit of 95% CI, the stronger the signal strength. The information component ( IC)-2 SD>0 ( SD is the standard deviation) was defined as a positive signal for BCPNN method, and the larger the IC-2 SD value, the stronger the signal. According to the preferred system organ class (SOC) and preferred term (PT) from terminology of adverse drug reactions in Medical Dictionary for Regulatory Activities, AEs were counted and classified. The risk signal with positive detection results from both ROR and BCPNN methods was determined as the AE risk signal of tafamidis and analyzed. Results:A total of 3 999 cases with tafamidis as the primary suspect drug were collected, including 2 942 males (73.6%), 688 females (17.2%), and 369 unknown cases (9.2%); 3 148 cases (78.7%) aged >65 years, 192 cases (4.8%) aged 18-65 years, 52 cases (1.3%) aged <18 years, and 607 cases (15.2%) were unknown; 1 064 patients were with cardiac amyloidosis, 872 patients with cardiac amyloidosis, 148 patients with peripheral nerve amyloidosis, and 176 with other diseases; 1 403 cases (35.1%) died. A total of 110 positive signals were screened with both ROR and BCPNN methods, involving 20 SOCs. The top 5 PTs of AE reports were dyspnea (338 cases), fatigue (301 cases), edema (167 cases), dizziness (111 cases), and fall (110 cases). The SOC involved were systemic lesions, neurological diseases, respiratory/thoracic and mediastinal diseases, examination, metabolic and nutritional diseases. The top 5 PTs ( ROR and the 95% CI lower limit) were early feeling of fullness (28.07, 11.64), lumbar spinal stenosis (26.73, 15.15), aortectasia (24.36, 9.11), hypoxia (22.64, 10.15), and cervical radiculopathy (22.13, 7.11). Four of the top 20 PTs in the AE reports were not recorded in the drug label, including dizziness, height loss, chest pain, and renal failure; 16 of the top 20 PTs in signal strength ( ROR method) were not recorded in the drug label, including lumbar spinal stenosis, aortic dilatation, physical decline, cervical radiculopathy, height reduction, carotid artery disease, hyperlipidemia, orthopnea, peripheral vein disease, benign prostatic hyperplasia, carpal tunnel syndrome, emaciation, foreign body sensation in the throat, immune thrombocytopenia, positional dizziness, and aortic atherosclerosis. Conclusion:Through data mining, it is found that early feeling of fullness, lumbar spinal stenosis, aortic dilatation, physical decline, and cervical radiculopathy may be the common adverse events of tafamidis, some risk signals are not recorded in the drug label, which should be paid attention to during the clinical use.
