FDA warns public vs use of drugs, vaccines with unproven COVID-19 treatment claims

Robie de Guzman

MANILA, Philippines – The Food and Drug Administration (FDA) has warned the public against using medicines or vaccines that have not been proven safe and effective in the treatment of novel coronavirus disease (COVID-19).

“Currently there are no registered drugs or vaccines that are licensed specifically for use in COVID-19 treatment or prevention,” the FDA said in a statement on Wednesday.

The FDA said there are on-going clinical trials to investigate the safety and efficacy of new and existing drugs, such as anti-viral, anti-bacterial, and anti-inflammatory agents for the treatment of COVID-19 infected individuals.

“The World Health Organization (WHO) recently launched the Solidarity Trial, a large-scale clinical trial participated by many countries (including the Philippines), which aims to identify evidenced-based treatment regimen for COVID-19,” the agency said.

It also said that manufacturers and vendors of unlicensed products such as PRODEX B and the Fabunan Antiviral Injections have been informed regarding the process and requirements to register their products with the FDA Center for Drug Regulation and Research (CDRR).

“No applications for product registration have been filed to date,” the FDA said.

“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,” it added.

The agency assured it would continue to ensure 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.

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