safety signal | CMAC

safety signal

Report of the Russian database on adverse drug reactions for COVID-19-related drugs with a focus on favipiravir

Objective. The purpose of this study is to systematize and comprehensively evaluate safety data on the drug favipiravir using the national pharmacovigilance database of the Russian Federation. Materials and Methods. The report is based on spontaneous reports in the national automated information system of pharmacovigilance of the Russian Federation for the reporting period from 01.01.2020 – 04.07.2022. To identify safety signals we used disproportionality analysis, to estimate consumption of favipiravir – indicator of the number of consumed DDDs, we additionally performed review of concomitant therapy as a risk factor for serious adverse reactions.