A recent study by the Keck School of Medicine at USC reveals that most FDA-approved COVID-19 treatments show few serious side effects, providing critical reassurance for high-risk patients.
In an encouraging development, researchers at the University of Southern California Keck School of Medicine have discovered that most FDA-approved treatments for COVID-19 have few, if any, serious side effects. Over the past four years, various treatment options — ranging from antiviral drugs like Paxlovid to monoclonal antibodies such as Evusheld — have been authorized to combat the pandemic.
The findings, detailed in a comprehensive review published in Open Forum Infectious Diseases, evaluated evidence from 54 U.S. studies, providing a robust evaluation of these therapies.
“The main message is, if your doctor puts you on Paxlovid, you don’t have to worry about serious side effects,” Susanne Hempel, a professor of clinical population and public health sciences and director of the Southern California Evidence Review Center (ERC) at the Keck School of Medicine, who supervised the research, said in a news release. “There are no serious adverse events for any of the oral medications that you’re taking at home for COVID-19.”
The comprehensive review spanned clinical trials and observational research, focusing on both inpatient and outpatient treatments. Crucially, only studies comparing COVID-19 therapies with standard care, placebos, or no treatment were included, to isolate the treatment effects from the disease itself. The exhaustive analysis even incorporated data submitted to the FDA and clinicaltrials.gov.
While no significant association with serious adverse events was found for oral antivirals like Paxlovid, treatments such as Actemra (tocilizumab) were associated with some risks, including infection and low white blood cell counts. Meanwhile, convalescent plasma transfusions were linked with risks such as internal bleeding, infection and blood clots.
The research was driven by the need to develop a countermeasure injury compensation table to determine eligibility for public benefits for those reporting adverse events. This initiative underscores the importance of basing such decisions on solid scientific evidence.
“Given the unique nature of the pandemic and the rapid production of treatments for COVID-19, the findings are very reassuring,” added co-author Jeffrey Klausner, a professor of clinical population and public health sciences at the Keck School of Medicine. “With a severe public health emergency like COVID-19, it is critical that there exists a government compensation program for treatment-related injuries that is based on the best scientific evidence. Now we know with additional certainty, that the treatments are safe without a high frequency of serious side effects.”
The research focused only on serious side effects, pursuant to a five-point scale developed by the National Institutes of Health. A rating of three or above indicates severe conditions requiring hospitalization while five signifies an adverse event that results in death.
“Manufacturers must submit very detailed records to the FDA for emergency authorization, so every adverse event should have been reported,” added first author Margaret Maglione, a project leader at the ERC. “We did not identify any serious adverse events that were not already described on the product packaging.”
These discoveries hold significant promise, particularly for individuals at high risk of severe COVID-19 complications, including those with advanced age or underlying health conditions. The study serves as a testament to the rigorous science that informs public policy and reassures the public about the safety of COVID-19 treatments.
Source: University of Southern California Keck School of Medicinee