Current FDA COVID-19 related actions and advice
The Delta variant of the virus behind the COVID-19 pandemic is causing a surge in cases and hospitalizations around the globe. At the same time, government entities like the US Food and Drug Administration (FDA) continue to review treatments, offer advice to drug and vaccine developers, and keep an eye out for unauthorized consumer products.
EUA amendments
The agency amended the emergency use authorization (EUA) for the combination drug REGEN-COV (casirivimab and imdevimab, administered together) to tag on the authorization of the treatment for emergency use as a post-exposure prophylaxis. The treatment is indicated as an appropriate preventative for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40kg) determined to be at high risk for developing severe COVID-19.
The FDA also revised its EUA for baricitinib (distributed by Eli Lilly under the brand name Olumiant) to authorize administering the drug by itself to treat hospitalized COVID-19 patients aged two years or older that require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Previously, the drug had been required to be administered with remdesivir (Veklury).
Additionally, the agency authorized an extension of the shelf life on Janssen’s refrigerated COVID-19 vaccine, from 4.5 months to 6 months. Healthcare professionals are advised to check the company’s website (www.vaxcheck.jnj) to check up-to-date expiration information for specific vaccine lots.
C19-related shortage
The FDA approved an abbreviated new drug application for dexamethasone sodium phosphate injection, indicated for a range of diseases like arthritis, blood disorders, hormone disorders, allergic reactions, skin diseases, eye disorders, breathing problems, bowel disorders, cancer, and immune system disorders. Side effects include fluid retention, sodium retention, impaired wound healing, and muscle weakness.
The drug is listed in the FDA Drug Shortage Database and in the Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency.
Unapproved items
While no consumer products to prevent, treat, or cure COVID-19 have to date received the FDA’s blessing for distribution and sale to consumers, companies continue to receive stern warnings from the agency for breaking the rules. The owner of the website RXMedKart.com received a reprimand for attempting to sell unapproved drugs for multiple diseases, including COVID-19 as did a firm called Blue Willow Biologics.
