Global COVID-19 pandemic and reporting behavior - An analysis of the Food and Drug Administration adverse events reporting system.

ABSTRACT:

Purpose

To describe the characteristics of adverse event reporting in the United States (US) Food and Drug Administration Adverse Event Reporting System (FAERS) before and after the outbreak of the COVID-19 pandemic.

Methods

We included all FAERS reports from the US and Canada from November 7, 2019 to July 15, 2020 and divided the study period into three equal time intervals (pre-pandemic, first pandemic, second pandemic). We focused on methotrexate, a broadly used drug unrelated to COVID-19, and (hydroxy)chloroquine, another broadly used drug implicated in COVID-19 treatment. Using descriptive statistics, we compared reporting characteristics before and after the COVID-19 outbreak.

Results

During the study period, 366 998 cases (60% female, median age: 59 years) were

SUBMITTER: Dorks M 

PROVIDER: S-EPMC8012989 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature