Investigating the Safety Profile of Fast‐Track COVID‐19 Drugs Using the FDA Adverse Event Reporting System Database: A Comparative Observational Study

ABSTRACT Background The US Food and Drug Administration (US FDA) granted emergency use authorization (EUA) for multiple coronavirus disease 2019 (COVID‐19) drugs as a medical countermeasure during the COVID‐19 pandemic. Despite these drugs' fast‐track nature, concerns persist regarding their ef...

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Veröffentlicht in:	Pharmacoepidemiology and drug safety 2024-11, Vol.33 (11), p.e70043-n/a
Hauptverfasser:	Kim, Hyo Jung, Yoon, Jeong‐Hwa, Lee, Kye Hwa
Format:	Artikel
Sprache:	eng
Schlagworte:	Adenosine Monophosphate - adverse effects Adenosine Monophosphate - analogs & derivatives Adenosine Monophosphate - therapeutic use Adolescent Adult adverse drug reaction Adverse Drug Reaction Reporting Systems - statistics & numerical data Adverse events Aged Alanine - adverse effects Alanine - analogs & derivatives Alanine - therapeutic use Alanine transaminase Antibodies, Monoclonal, Humanized - adverse effects Antiviral Agents - adverse effects Antiviral Agents - therapeutic use Child Child, Preschool Coronaviruses COVID-19 COVID-19 - epidemiology COVID-19 Drug Treatment Cytidine - analogs & derivatives Databases, Factual - statistics & numerical data Diarrhea Drug Combinations Drug development Drugs FDA adverse event reporting system Female Humans Hydroxylamines Infant Male Middle Aged Observational studies Pharmacovigilance post‐marketing surveillance Product Surveillance, Postmarketing - methods Product Surveillance, Postmarketing - statistics & numerical data real‐world data Regression analysis Ritonavir Ritonavir - adverse effects Safety Side effects Statistical analysis United States - epidemiology United States Food and Drug Administration Young Adult
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