A Rapid Systematic Review of U.S. Food and Drug Administration-Authorized COVID-19 Treatments - Takeaways - MDSpire

A Rapid Systematic Review of U.S. Food and Drug Administration-Authorized COVID-19 Treatments

  • 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

  • April 11, 2025

  • 0 min

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  • 1

    The review assessed serious adverse events (SAEs) associated with FDA-authorized COVID-19 treatments, including antivirals and monoclonal antibodies.

  • 2

    Fifty-four studies were included, with 31 being randomized controlled trials, focusing on the safety of treatments in hospitalized COVID-19 patients.

  • 3

    Insufficient evidence linked antivirals and spike protein receptor-binding antibodies to SAEs, while tocilizumab may elevate risks of neutropenia and infection.

  • 4

    Convalescent plasma was associated with thrombotic events and infections in patients with hematologic cancers, indicating moderate certainty of risk.

  • 5

    The review emphasizes the need for continued monitoring of rare toxicities in clinical practice despite the authorization of COVID-19 treatments.

Original Source(s)

A Rapid Systematic Review of U.S. Food and Drug Administration-Authorized COVID-19 Treatments

  • 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

  • April 11, 2025

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