Off-Label Use of Hydroxychloroquine in COVID-19: Analysis of Reports of Suspected Adverse Reactions From the Italian National Network of Pharmacovigilance.

ABSTRACT: This study aimed to characterize adverse drug reactions (ADRs) to hydroxychloroquine in the setting of COVID-19, occurring in Italy in the period March to May 2020. The analysis of the combination therapy with azithromycin or/and lopinavir/ritonavir as well as a comparison with ADRs reported throughout 2019 was performed. ADRs collected by the Italian National Network of Pharmacovigilance were analyzed for their incidence, seriousness, outcome, coadministered drugs, and Medical Dictionary for Regulatory Activities classification. A total of 306 reports were gathered for the quarter of 2020: 54% nonserious and 46% serious, and half of the latter required either the hospitalization or its prolongation. However, most of them were either completely recovered (26%) or in the process of recovery

SUBMITTER: Fallani E 

PROVIDER: S-EPMC9011412 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature