Baseless Claims of "Prodex-B" as Anti-Viral Treatment for COVID-19

March 30, 2020

FDA ADVISORY NO. 452-20

 

The Food and Drug Administration (FDA) reiterates to all health facilities and health professionals to follow the recommended treatment guidelines endorsed by the Department of Health (DOH) and the medical societies. This is in reference to the baseless claims on drug combination for the treatment and prevention of COVID-19.

The drug combination of Procaine and Dexamethasone with Vitamin B called "Prodex-B" is circulating in various media platforms and claims that it has promising effects against viral infections and diseases. However upon verification, the drug product "Prodex-B" is unregistered in this Office.

Procaine is an anesthetic used to reduce pain on injections, while Dexamethasone is a corticosteroid which must be used cautiously due to its side effects including immunosuppression or weaker immune system leading to vulnerability to infections. Furthermore, unregistered drug products have no guaranteed quality, safety and efficacy data which may lead to patient harm.

All consumers who have received the aforementioned drug are advised to monitor for any adverse reactions. For any observed adverse reaction, the individuals are advised to seek medical attention immediately and report to this Office at [email protected] and at E-Report at [email protected].

(SGD.) ROLANDO ENRIQUE D. DOMINGO, MDDirector General