Systematic Review of FDA-Authorized COVID-19 Treatments and Serious Adverse Events

Overview

This systematic review evaluated serious adverse events (SAEs) associated with FDA-authorized COVID-19 treatments including antivirals, monoclonal antibodies, and convalescent plasma. The analysis found no strong evidence linking antivirals or spike protein receptor-binding antibodies to SAEs, but identified potential risks of neutropenia and infection with tocilizumab, and thrombotic, bleeding, and infectious events with convalescent plasma in specific populations.

Background

During the COVID-19 pandemic, the US FDA authorized multiple treatments under emergency use to mitigate disease severity. Understanding the safety profile of these interventions is critical, especially given the high baseline risk of serious medical complications in hospitalized COVID-19 patients. This review focused on controlled studies with US sites to assess serious harms associated with antivirals, monoclonal antibodies, and convalescent plasma. The findings aim to inform clinical decision-making and support injury compensation programs.

Data Highlights

Key Findings

• No significant association between antivirals or spike protein receptor-binding antibodies and serious adverse events was found.
• Tocilizumab may increase the risk of neutropenia (moderate certainty) and infections (limited certainty) in hospitalized patients.
• Convalescent plasma may be linked to thrombotic events, bleeding, and infections, particularly in patients with hematologic malignancies.
• Serious adverse events must be interpreted cautiously due to the high baseline risk of complications from severe COVID-19 itself.
• Studies included only those with at least one US site to ensure applicability to US populations and compensation programs.

Clinical Implications

Clinicians should continue prescribing FDA-authorized COVID-19 treatments based on clinical indications while monitoring for rare but potentially serious adverse events. Special caution is warranted when using tocilizumab and convalescent plasma in vulnerable populations such as hospitalized patients and those with hematologic cancers. Ongoing vigilance and reporting of adverse events in clinical practice remain essential to identify uncommon toxicities.

Conclusion

FDA-authorized COVID-19 treatments generally exhibit acceptable safety profiles with limited evidence of serious harms. However, certain therapies like tocilizumab and convalescent plasma may pose increased risks in specific patient groups, underscoring the need for careful patient selection and monitoring.

References

1. US FDA/HRSA/AHRQ 2024 -- A Swift Systematic Review of COVID-19 Treatments Authorized by the U.S. Food and Drug Administration