https://www.cidrap.umn.edu/covid-19...zed-covid-drugs-not-tied-serious-side-effects
Review: Most FDA-authorized COVID drugs not tied to serious side effects
Mary Van Beusekom, MS
Today at 2:36 p.m.
COVID-19
Convalescent plasma, antivirals, antibodies
Researchers from the University of Southern California (USC) searched the literature for papers on FDA-authorized COVID-19 therapies published through December 2023 and identified 54 that included at least one US healthcare location, including 31 randomized controlled trials and 23 controlled observational studies. The studies spanned hospital and outpatient treatments and compared COVID-19 drugs with standard care, a placebo, or no treatment.
The study included convalescent plasma; the antivirals remdesivir, nirmatrelvir-ritonavir (Paxlovid), and molnupiravir; and the monoclonal antibodies (mAbs) bamlanivimab-etesevimab, bebtelovimab, casirivimab-imdevimab, sotrovimab, tixagevimab-cilgavimab, and tocilizumab (Actemra).
The US Health Resources and Services Administration Countermeasures Injury Compensation Program requested the study to inform development of a treatment injury compensation table, which is used to determine whether patients and families who report SAEs are eligible for public benefits. The Agency for Healthcare Research and Quality commissioned the research.
In general, SAEs are considered injuries that warrant hospitalization and those that lead to a significant loss of function or disability.
Tocilizumab may have led to neutropenia, infection
The investigators found no link between any SAE not already identified on the product packaging with oral COVID-19 antivirals such as Paxlovid or mAbs that bind to the virus's spike protein. mAbs were administered intravenously in the hospital, but some lost emergency-use authorization after showing no effectiveness against SARS-CoV-2 variants.
Hospitalized patients taking tocilizumab, however, may have been at increased risk for neutropenia (low white blood cell counts; moderate certainty) and infection (limited certainty). Tocilizumab works somewhat differently than other MABs, the researchers noted.
Convalescent plasma (blood product donated by COVID-19 survivors) may have led to blood clots (limited certainty), as well as internal bleeding and infection in patients with hematologic cancers (moderate certainty).
Inclusion of studies that did not involve a US healthcare facility could change the findings, the authors cautioned.
COVID itself may have caused adverse effects
"Severe COVID-19 infection may have serious consequences, especially in hospitalized patients with comorbidities," the researchers wrote. "These consequences may be confused with toxicities of the interventions. Based on our analysis, approved treatments for COVID-19 should be prescribed as clinically indicated, although continued vigilance is warranted to identify rare and potentially significant toxicities that may arise in clinical practice."
The main message is, if your doctor puts you on Paxlovid, you don't have to worry about serious side effects.
Susanne Hempel, PhD
In a USC Keck School of Medicine press release, senior author Susanne Hempel, PhD, said, "The main message is, if your doctor puts you on Paxlovid, you don't have to worry about serious side effects. There are no serious adverse events for any of the oral medications that you're taking at home for COVID-19."
Coauthor Jeffrey Klausner, MD, MPH, called the results very reassuring: "Now we know with additional certainty, that the treatments are safe without a high frequency of serious side effects."
Review: Most FDA-authorized COVID drugs not tied to serious side effects
Mary Van Beusekom, MS
Today at 2:36 p.m.
COVID-19
COVID-19 treatments authorized for emergency use by the US Food and Drug Administration (FDA) are associated with few serious adverse effects (SAEs), according to a rapid systematic review published late last week in Open Forum Infectious Diseases.Convalescent plasma, antivirals, antibodies
Researchers from the University of Southern California (USC) searched the literature for papers on FDA-authorized COVID-19 therapies published through December 2023 and identified 54 that included at least one US healthcare location, including 31 randomized controlled trials and 23 controlled observational studies. The studies spanned hospital and outpatient treatments and compared COVID-19 drugs with standard care, a placebo, or no treatment.
The study included convalescent plasma; the antivirals remdesivir, nirmatrelvir-ritonavir (Paxlovid), and molnupiravir; and the monoclonal antibodies (mAbs) bamlanivimab-etesevimab, bebtelovimab, casirivimab-imdevimab, sotrovimab, tixagevimab-cilgavimab, and tocilizumab (Actemra).
The US Health Resources and Services Administration Countermeasures Injury Compensation Program requested the study to inform development of a treatment injury compensation table, which is used to determine whether patients and families who report SAEs are eligible for public benefits. The Agency for Healthcare Research and Quality commissioned the research.
In general, SAEs are considered injuries that warrant hospitalization and those that lead to a significant loss of function or disability.
Tocilizumab may have led to neutropenia, infection
The investigators found no link between any SAE not already identified on the product packaging with oral COVID-19 antivirals such as Paxlovid or mAbs that bind to the virus's spike protein. mAbs were administered intravenously in the hospital, but some lost emergency-use authorization after showing no effectiveness against SARS-CoV-2 variants.
Hospitalized patients taking tocilizumab, however, may have been at increased risk for neutropenia (low white blood cell counts; moderate certainty) and infection (limited certainty). Tocilizumab works somewhat differently than other MABs, the researchers noted.
Convalescent plasma (blood product donated by COVID-19 survivors) may have led to blood clots (limited certainty), as well as internal bleeding and infection in patients with hematologic cancers (moderate certainty).
Inclusion of studies that did not involve a US healthcare facility could change the findings, the authors cautioned.
COVID itself may have caused adverse effects
"Severe COVID-19 infection may have serious consequences, especially in hospitalized patients with comorbidities," the researchers wrote. "These consequences may be confused with toxicities of the interventions. Based on our analysis, approved treatments for COVID-19 should be prescribed as clinically indicated, although continued vigilance is warranted to identify rare and potentially significant toxicities that may arise in clinical practice."
The main message is, if your doctor puts you on Paxlovid, you don't have to worry about serious side effects.
Susanne Hempel, PhD
In a USC Keck School of Medicine press release, senior author Susanne Hempel, PhD, said, "The main message is, if your doctor puts you on Paxlovid, you don't have to worry about serious side effects. There are no serious adverse events for any of the oral medications that you're taking at home for COVID-19."
Coauthor Jeffrey Klausner, MD, MPH, called the results very reassuring: "Now we know with additional certainty, that the treatments are safe without a high frequency of serious side effects."