Latest FDA COVID-19 news
While the US inches closer to possible approval of one or more COVID-19 vaccines in the very near future, the US Food and Drug Administration (FDA) continues to monitor development of potential treatments, issue advice for test developers, and keep an eye out for potentially harmful unapproved items.
The FDA issued an emergency use authorization (EUA) for baricitinib in combination with remdesivir to treat COVID-19 in hospitalized adults (and children 2 years or older) receiving supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
The agency reports in a clinical study of such patients, the combination of drugs was shown to reduce time to recovery within 29 days after initiating treatment compared to patients who received a placebo with remdesivir. However, FDA officials reminded that baricitinib is not authorized or approved as a stand-alone treatment for the virus.
The FDA issued another EUA for the combination use of casirivimab and imdevimab for the treatment of mild to moderate COVID-19 in adults patients, and pediatric patients 12 years or older weighing at least 40 kg (88 lbs) at high risk for progressing to severe COVID-19. This also includes patients 65 years or older, or who have certain chronic medical conditions.
According to the FDA, casirivimab and imdevimab, administered together were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. The two drugs must be administered together via intravenous (IV) infusion.
To date, the FDA has not approved any products intended to prevent, treat, diagnose or cure COVID-19 for direct sale to consumers. Since the onset of the pandemic, the agency has issued warnings of varying degrees of severity to companies fraudulently offering such products to the public.
- The FDA issued a warning letter jointly with the Federal Trade Commission (FTC) to Pro Breath MD (dba Dentist Select and OraCare) for selling a number of fake COVID-19 treatments, including OraCare Health Rinse and OraCare Operatory Pre-Rinsing Set. The letter directed the firm to immediately cease distribution, or risk more dire consequences.
- Vibrant Health Care received a warning for marketing an unapproved umbilical cord derived cellular product to treat COVID-19.
- Avazo-Healthcare was cited for selling adulterated and misbranded COVID-19 test kits and unapproved drug products, as well as CBD products they claimed could treat the virus.
- ChromaDex, Innovative Medicine, Red Moon Herbs, and Sage Woman Herbs (dba Sage Consulting & Apothecary) also all received warning letters for offering unapproved COVID-19 treatments.