To assess potential serious harms associated with specific COVID-19 treatments authorized by the FDA, including convalescent plasma, antivirals, and monoclonal antibodies.
Key Findings:
Insufficient evidence of association of any SAE with antivirals and spike protein receptor-binding antibodies, indicating a need for further investigation.
Tocilizumab may be associated with elevated risk of neutropenia and infection in hospitalized COVID-19 patients, warranting caution in its use.
Convalescent plasma may be linked to thrombotic events, bleeding events, and infections in patients with hematologic cancers, highlighting the need for careful patient selection.
Interpretation:
Severe COVID-19 may lead to serious consequences that could be confused with treatment toxicities; thus, careful monitoring of patients for adverse effects and clinical outcomes is essential.
Limitations:
Inclusion of studies without a US site could alter findings, potentially affecting the generalizability of results.
Potential underreporting of adverse events due to study design may limit the comprehensiveness of the findings.
Conclusion:
Approved COVID-19 treatments should be prescribed as clinically indicated, with ongoing vigilance for rare toxicities and a commitment to further research.
by Margaret A Maglione, Jeffrey D Klausner, Patricia K Wirnkar, Ivan Fallarme, Rozhin Lak, Kimny Sysawang, Ning Fu, Sachi Yagyu, Aneesa Motala, Danica Tolentino, Susanne Hempel
