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Home Articles Vol 32,2023 No.4 Detail

Data mining and analysis of adverse drug events signals for Loratadine in children based on FAERS database

Published on Apr. 27, 2023Total Views: 1643 times Total Downloads: 583 times Download Mobile

Author: Yi-Bin ZHAI 1 Chuan-Cui LUO 1, 2 Zhen ZENG 1 Ling JIANG 1 Jiang-Ping LI 1 Wen PENG 1 Jian LI 1 Liang YANG 1

Affiliation: 1. Department of Pharmacy, the Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guiyang 550001, China 2. School of Chemistry and Biological Engineering, Yichun University, Yichun 336000, Jiangxi Province, China

Keywords: Loratadine Medications for children Medication error Data mining FAERS database Pharmacovigilance

DOI: 10.19960/j.issn.1005-0698.202304002

Reference: Yi-Bin ZHAI, Chuan-Cui LUO, Zhen ZENG, Ling JIANG, Jiang-Ping LI, Wen PENG, Jian LI, Liang YANG.Data mining and analysis of adverse drug events signals for Loratadine in children based on FAERS database[J].Yaowu Liuxingbingxue Zazhi,2023, 32(4): 367-375.DOI: 10.19960/j.issn.1005-0698.202304002.[Article in Chinese]

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Abstract

Objective By mining the adverse event (ADE) signals for loratadine in children from real-world data, to find the potential ADE types, and to provide evidence for rational administration of drug.

Methods ADE reports from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database from the first quarter of 2013 to the second quarter of 2021 were extracted, and the cases under 18 years old who used loratadine were screened out. Proportional reporting ratio (PRR) method and reporting odds ratio (ROR) method were used for data mining, and the Medical Dictionary for Regulatory Activities (MedDRA) was used to systematically classify the ADE signals.

Results A total of 19 237 reports were included after screening, including 1 738 ADE and 186 signals, involving 24 system/organ classifications (injury, poisoning and procedural complications: 22.49%) and 38 standardised MedDRA queries (medication error: 15.74%). Blepharochalasis and agoraphobia with strong signal were not recorded in the drug instructions.

Conclusion It is found after analysis by PRR and ROR methods that although the use of loratadine in children has good safety, there are certain medication errors. It is suggested to strengthen monitoring in clinical medication, use in strict accordance with the provisions of the drug labels, improve the quality of pharmaceutical services, and ensure the safe and effective medication for children.

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