Detection and evaluation of adverse event signals of ribavirin, lopinavir / ritonavir and chloroquine phosphate based on FAERS database

doi:10.19803/j.1672-8629.2022.02.20

Abstract

Abstract: Objective To mine and evaluate the safety signals of ribavirin, lopinavir/ ritonavir, chloroquine phosphate and to provide reference for clinical rational drug use. Methods The reporting odd ratio (ROR) data mining algorithm was used to investigate ADE risk signals from FAERS submitted to the FDA between January 1, 2004 and December 31, 2019. The top 30 reporting ADE and designated medical event (DME) signals were the focus of analysis. Results The top 30 ADEs of the three target drugs were similar. What was more significant was the signals from the hematological toxicity of ribavirin, the hepatotoxicity, cardiac toxicity and immune reconstitution inflammatory syndrome of lopinavir / ritonavir and from the cardiotoxicity and ocular toxicity of chloroquine phosphate. The common DME signals of the three drugs were involved in liver failure, hemolysis, hemolytic anemia, bone marrow failure and Steven-Johnson syndrome. Conclusion The detection of ADE signals based on the real-world spontaneous reporting database can contribute to safety evaluation of ribavirin, lopinavir/ritonavir, chloroquine phosphate while reducing the risk of clinical medication.

Key words: adverse drug event, ribavirin, lopinavir/ritonavir, chloroquine phosphate, signal detection

CLC Number:

R979.9

ZHOU Ruiou, JI Huanhuan, GONG Li, ZHANG Ni, SONG Lin. Detection and evaluation of adverse event signals of ribavirin, lopinavir / ritonavir and chloroquine phosphate based on FAERS database[J]. Chinese Journal of Pharmacovigilance, 2022, 19(2): 205-209.

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