CEBU CITY, Philippines—The Food and Drug Administration (FDA) cautioned the public against using drugs or vaccines with unproven claims to be safe and effective as treatment for the coronavirus disease 2019 (COVID-19).
The FDA issued the warning in a statement posted on its Facebook page. “Currently there are no registered drugs or vaccines that are licensed specifically for use in COVID-19 treatment or prevention.”
However, the FDA noted that there are ongoing clinical trials to investigate the safety and efficacy of new and existing drugs, such as anti-viral, anti-bacterial, and anti-malarial agents in the treatment of COVID-19 patients.
Recently, the World Health Organization (WHO) launched the Solidarity Trial, a large-scale clinical trial participated by many countries (including the Philippines), which aims to identify evidence-based treatment regimen for COVID-19.
The agency has informed the manufacturers and vendors of unlicensed products such as Vitamin B called “Prodex-B” and the Fabunan Antiviral Injections on the process and requirements for the registration of their products with the FDA Center for Drug Regulation and Research (CDRR).
As of Wednesday, the FDA has yet to receive any application for registration of treatment or prevention of the coronavirus disease 2019.
“Until such products are proven safe and effective for use in the treatment of COVID-19 they cannot be dispensed to the public nor can therapeutic claims be made,” the FDA stressed.
The agency had earlier issued an advisory regarding the use of Procaine and Dexamethasone together with Prodex-B. There were claims circulating in various media platforms that the combination of these two drugs with Prodex-B allegedly has promising effects against viral infections and diseases.
Procaine is an anesthetic used to reduce pain on injections. 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
On the other hand, “Prodex-B” has not been registered with the FDA.
The FDA remains vigilant in ensuring the safety and efficacy of products to protect public health and commits to cooperate with all agencies to ensure prompt response to this global health crisis./dbs