Detection and evaluation of the signals of amlodipine and lercanidipine based on FAERS database
- VernacularTitle:基于FAERS数据库对氨氯地平和乐卡地平信号的检测与评价
- Author:
Guizun ZHONG
1
;
Ni ZHANG
2
;
Hongli WANG
1
;
Siqi CHEN
1
;
Li GONG
3
;
Lingyun PAN
4
;
Yuntao JIA
5
Author Information
1. School of Pharmacy，Chongqing Medical University，Chongqing 400016，China
2. Dept. of Pharmacy，Army Medical Characteristic Center of PLA，Chongqing 400042，China
3. Key Lab of Researches on Transformation of Tumor Metastasis and Individualized Diagnosis and Treatment，Chongqing University Cancer Hospital，Chongqing 400030，China
4. Dept. of Pharmacy，Chongqing University Cancer Hospital，Chongqing 400030，China
5. Dept. of Pharmacy，Children’s Hospital Affiliated to Chongqing Medical University/Key Laboratory of Child Development Disease Research，Ministry of Education/National Science and Technology Cooperation Base of Major Child Development Diseases/Chongqing Key Laboratory of Pediatrics/National Clinical Medicine Research Center of Child Health and Diseases，Chongqing 400014，China
- Publication Type:Journal Article
- Keywords:
amlodipine;
lercanidipine;
adverse drug event;
signal detection;
safe drug use;
hypertension
- From:
China Pharmacy
2022;33(21):2647-2653
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To detect and evaluate the signals of amlodipine and lercanidipine -induced adverse drug events （ADE）. METHODS All ADE reports about “amlodipine”and“lercanidipine”were searched from FAERS database during Jan . 1st，2004 to Sept . 30th，2021. Reported odds ratio and Bayesian confidence propagation neural network were used to detect ADE signals. The moderately strong signals and strong signals in key systems were selected for analysis . RESULTS From FAERS database，249 657 and 10 558 reports were extracted with amlodipine and lercanidipine as suspect drugs ，respectively. In this study，62 and 58 signals related to amlodipine and lercanidipine were detected respectively . At the same time ，moderately strong signals of peripheral edema ， hypotension， orthostatic hypotension and hypovolemic shock were detected in the twodrugs，all of which were common adverse reactions of the two drugs. The special ADEs detected in this study were as follows： in the respiratory system ， chest and mediastinaldisease system ，strong signals of non -cardiogenic pulmonary edema were detected for amlodipine ，and strong signals of dyspnea at rest for lercanidipine ；in gastrointestinal diseases ，strong signals of gingival hypertrophy were detected only for amlodipine；in skin and subcutaneous tissue disease system ，moderately strong signals related to “vasculitis”were detected for both drugs，moderately strong signals related to linear IgA disease were detected for amlodipine ，and moderately strong signals related to bullous dermatitis were detected for lercanidipine ；in the renal and urinary system disease system ，the signals of acute renal injury were detected for both drugs （amlodipine was detected as a moderately strong signal ，and lecardipine was detected as a strong signal ）； in the mental system ，moderately strong signals related to suicide were detected for amlodipine . Both hypotension and acute renal injury ranked in the top two in the number of reports of the two drugs . The time scan results of the information component （IC）of this study showed that the IC values of non -cardiogenic pulmonary edema and suicide completion signals of amlodipine increased from 0.76，－0.49 to 4.48 and 1.95 respectively，and the confidence intervals narrowed from （－0.44，1.97），（－1.01，0.03）to （4.24，4.72）and（1.90，2.01）respectively during 2004 to 2021，suggesting that the signals kept stable . CONCLUSIONS The risks of peripheral edema ，hypotension，arrhythmia，pulmonary edema ，gingival hyperplasia ，skin related ADE ，acute renal injury ， depression and suicide should be alert when using amlodipine and lercanidipine in clinic .
