The Food and Drug Administration (FDA) on Monday warned the public against an unregistered cocktail of drugs being touted as a cure for Covid-19, and called on those who have taken it to report adverse reactions.
The drug cocktail, called Prodex-B, is the subject of an online petition to Health Secretary Francisco Duque III by JC delos Reyes, owner of a health clinic in Olongapo and a one-time presidential candidate.
The FDA described as “baseless” claims that Prodex-B can be used 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,” the FDA said in an advisory dated March 30, 2020.
The FDA explained that 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,” the FDA said.
“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 cdrr@fda.gov.ph and at E-Report at ereport@fda.gov.ph,” it added.
Delos Reyes’ online petition, titled “Urgent appeal to DOH for the immediate testing of Prodex-B Anti-Viral against COVID-19,” has obtained more than 13,000 signatures as of Monday.
The petition states: “We have focused enough on quarantines, lock-downs, testing kits, PPEs, more money from Congress. These are preventive and defensive, very expensive and will drain us in this battle of attrition with the virus. WHAT WE NEED IS AN ANTI-VIRAL TREATMENT, AND WE NEED IT NOW! WITHOUT THIS WE LOSE THE WAR!”
The petition itself states that Prodex-B has been tried only on HIV and dengue patients.
On Facebook, Delos Reyes appealed to the FDA and medical experts not to brand Prodex-B a “hoax.”
“We never said it was a cure, we said, a possible cure. There is a big difference,” he said.
“We were merely offering to help the government in a way we know, out of civic duty, with no cost, to offer some idea, a novel idea, to fight a novel virus.(PressONE.ph)