Global COVID-19 pandemic and reporting behavior - An analysis of the Food and Drug Administration adverse events reporting system.
Pharmacoepidemiol Drug Saf
; 30(6): 707-715, 2021 06.
Article
in English
| MEDLINE | ID: covidwho-1137058
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 submitted to FAERS. The daily median number of reports (1796 in the pre-pandemic, 1810 in the second pandemic time interval) and other characteristics remained stable. The daily median number of reports for methotrexate decreased from 28 in the pre-pandemic to 15 in the second pandemic time interval, with no considerable differences in other characteristics. The daily median number of reports for (hydroxy)chloroquine increased slightly from 1 in the pre-pandemic to 3 in the second pandemic time interval, while there were also changes in the demographics of cases and an increase in the proportion of cases reported by health professionals.CONCLUSIONS:
The overall reporting to FAERS did not change after the outbreak of the COVID-19 pandemic. However, some stimulated reporting was observed for (hydroxy)chloroquine, highlighting the need for caution when conducting pharmacovigilance analyses with substances related to COVID-19.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
United States Food and Drug Administration
/
Adverse Drug Reaction Reporting Systems
/
COVID-19 Drug Treatment
Type of study:
Experimental Studies
/
Observational study
Limits:
Adolescent
/
Adult
/
Aged
/
Child
/
Child, preschool
/
Female
/
Humans
/
Infant
/
Male
/
Middle aged
Country/Region as subject:
North America
Language:
English
Journal:
Pharmacoepidemiol Drug Saf
Journal subject:
Epidemiology
/
Drug Therapy
Year:
2021
Document Type:
Article
Affiliation country:
Pds.5217
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