FDA flags unregistered drug allegedly effective vs COVID-19

MANILA, Philippines — The Food and Drug Administration (FDA) has warned the public against an unregistered drug product called “Prodex-B”, which allegedly has promising effects against the coronavirus disease 2019 (COVID-19).

In an advisory Monday, the FDA said Prodex-B, a combination of Procaine and Dexamethasone with Vitamin B, has “no guaranteed quality, safety and efficacy data which may lead to patient harm.”

“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,” the FDA said.

Consumers who have received the 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 the same to the FDA.

The respiratory disease has so far infected over 720,000 worldwide, nearly 34,000 of whom have died.

In the Philippines, 1,418 have been infected with 71 deaths and 42 recoveries.