Investigating the Safety Profile of Fast-Track COVID-19 Drugs Using the FDA Adverse Event Reporting System Database:...

Area of Science:

• Pharmacovigilance
• Real-world evidence
• Drug safety

Background:

• US FDA granted emergency use authorization (EUA) for COVID-19 drugs during the pandemic.
• Concerns exist regarding the efficacy and adverse effects of these fast-track medications.
• Continuous safety surveillance is vital for understanding drug profiles.

Purpose of the Study:

• To compare adverse drug reactions (ADRs) of four fast-track COVID-19 drugs.
• To explore the utility of real-world data for prompt clinical feedback.
• To assess post-marketing safety of bebtelovimab, molnupiravir, nirmatrelvir/ritonavir, and remdesivir.

Main Methods:

• Utilized the FDA Adverse Event Reporting System (FAERS) database (January 2020 - June 2022).
• Analyzed ADRs of four COVID-19 drugs as the primary suspect drug group versus other drugs.
• Employed disproportionality analysis (reporting odds ratios) and logistic regression to identify significant ADR signals and serious outcomes.

Main Results:

• 17,275 cases involving the four COVID-19 drugs were analyzed.
• Identified significant ADRs including infusion-related reactions (bebtelovimab), diarrhea (molnupiravir), dysgeusia (nirmatrelvir/ritonavir), and increased alanine aminotransferase (remdesivir).
• Remdesivir showed a higher occurrence of death or life-threatening ADRs compared to controls.

Conclusions:

• Potential ADRs associated with COVID-19 drugs were identified, offering real-world safety insights.
• Real-world data and real-time safety reviews are effective for detecting ADR signals of fast-track drugs.
• Emphasized the importance of continuous surveillance, efficient data processing, and automated pipelines for safety reviews.