Safety of an Anti-novel Coronavirus Pneumonia Drug：Chloroquine Phosphate

doi:10.19803/j.1672-8629.2021.02.03

Abstract

Abstract: Objective To analyze safety signals of chloroquine phosphate based on the data of the US FAERS and Canada Vigilance in order to provide reference for safe and rational medication against novel coronavirus pneumonia. Methods The reporting odds ratio method (ROR) and the information component method (IC) were adopted to detect ADR signals of the data of the FAERS from 2015 to 2019 and of Canada Vigilance from 1965 to 2019. Results From FAERS and Canada Vigilance, a total of 126 cases and 54 cases of adverse drug reactions were obtained respectively, and a total of 58/32, 9/2 ADR signals were detected by ROR and IC from FAERS and Canada Vigilance. The SOC with the largest number of reports of ADR signals in FAERS was injury, poisoning and procedural complications (85 cases, 16.2%), while PT with the strongest signal was restrictive cardiomyopathy (n=9, ROR=18.92, IC=4.24), compared with skin and subcutaneous tissue disorders (23 cases, 18.7%) and photosensitivity reaction (n=9, ROR=17.01, IC=4.08) respectively in Canada Vigilance. Conclusion Long-term clinical use of chloroquine phosphate can cause severe ADRs, so this drug should be used with caution in patients with heart-based diseases and nervous system-based diseases.

Key words: chloroquine phosphate, novel coronavirus pneumonia, adverse drug reaction, signal detection

CLC Number:

R978.7

LYU Qiang, YAN Jiayang, ZHANG Wangzheqi, YE Xiaofei, GUO Xiaojing. Safety of an Anti-novel Coronavirus Pneumonia Drug：Chloroquine Phosphate[J]. Chinese Journal of Pharmacovigilance, 2021, 18(2): 110-114.

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