FDA warns vs drug cocktail pushed as possible ‘game changer’ vs COVID-19

Christian V. Esguerra, ABS-CBN News

Posted at Mar 30 2020 02:06 PM

MANILA—The Food and Drug Administration (FDA) on Monday cautioned the public against a non-commercial flu and dengue drug cocktail touted as a possible “game changer” in the treatment for the new coronavirus, which has killed 71 out of 1,418 infected patients in the Philippines as of Sunday.

The FDA described as “baseless” claims that the drug Prodex-B could work against COVID-19, saying it’s not registered with the agency and could have harmful side effects.

“Unregistered drug products have no guaranteed quality, safety and efficacy data which may lead to patient harm,” the FDA said in an advisory.

“All consumers who have received the drug are advised to monitor for any adverse reactions.”

An online petition cited doctors claiming that Prodex-B “can arrest” the virus causing COVID-19, because the disease “share similar symptoms with influenza.”

“The drug cocktail Prodex-B is almost 100 percent successful against Influenza and Dengue which are viral diseases,” said the petition, which asked the Department of Health to vet its efficacy.

“Anything that claims 100-percent effective is garbage,” Dr. Edsel Maurice Salvaña, an infectious disease specialist from the University of the Philippines’ National Institutes of Health, told ABS-CBN News.

“It’s a hoax,” he added, citing the absence of a randomised controlled trial. “If it hasn’t gone through the proper process, you need to be careful.”

John Carlos Delos Reyes, an Olongapo City-based businessman who started the online petition, clarified that he was in fact asking health authorities to determine whether the drug combination was effective against COVID-19.

“In all our social media platforms… never have we claimed it as a cure,” he said in a draft letter to FDA director general Eric Domingo. 

“On the contrary, we have been asking the DOH to take notice and take jurisdiction, if need be, given this national emergency.”

In the petition, he said doctors who had conducted previous studies on Prodex-B were ready and willing to share what they know and disclose what they have, so the government can begin the process of vetting this remaining medical alternative that could very well be the game changer against this pandemic.”

“No names here, no profits to be made, no politics, just turning over to government and health authorities what we have, for love of country and humanity,” said Delos Reyes, who runs a wellness clinic.