Potential Signals of COVID-19 as an Effect Modifier of Adverse Drug Reactions

The objective of this study was to identify potential signals of effect modification of adverse drug reactions by statistical reporting interactions with COVID-19 infection (SRIsCOVID-19) in a large spontaneous reporting database.METHODS: Data from the US Food and Drug Administration Adverse Event Reporting System through the second quarter of 2020 were used. Three-dimensional disproportionality analyses were conducted to identify drug-event-event (DEE) combinations, for which 1 of the events was COVID-19 infection, that were disproportionately reported. Effect size was quantified by an interaction signal score (INTSS) when COVID-19 was coreported as an adverse event or an indication (INTSSCOVID-19). An SRICOVID-19 exists when the calculated INTSSCOVID-19 is >2. The analyses focused on pandemic-emergent SRIsCOVID-19. Screening for extreme duplication of cases was applied. To assess possible reporting artifacts during the early pandemic as an alternative explanation for pandemic-emergent SRICOVID-19, we repeated the analyses with an additional year of data to gauge temporal stability of our findings.FINDINGS: When examining DEE interactions, 193 emergent SRIsCOVID-19 were identified, involving 44 drugs and 88 events, in addition to COVID-19 infection. Of the 44 drugs recorded, most were immunosuppressant or modulatory drugs, followed by antivirals. Seven drugs (eg, azithromycin) were identified in emergent SRIsCOVID-19 with preferred terms representing off-label use for pre...
Source: Clinical Therapeutics - Category: Drugs & Pharmacology Authors: Source Type: research