'It may not be effective for COVID-19' -- FDA withdraws approval for chloroquine

‘It may not be effective for COVID-19’ — FDA withdraws approval for chloroquine

June 15

19:30 2020

Print This Article

The United States Food and Drug Administration (FDA) says it is withdrawing its approval for the emergency use of two anti-malaria drugs for the treatment of COVID-19.

The FDA said on Monday that both hydroxychloroquine and chloroquine may not be effective for the infection.

In March, the agency had authorised the drugs to be used to treat COVID-19 patients.

But in a letter by Denise M. Hinton, its chief scientist, the FDA said the request to revoke the authorisation came from the Biomedical Advanced Research and Development Authority (BARDA), a unit of the US Department of Health and Human Services.

It said BARDA also found out that the drug’s potential benefits for treatment of COVID-19 do not outweigh its potential risks.

The letter read: “Like BARDA’s earlier request to FDA to issue the EUA, BARDA’s request to revoke the EUA is part of a collaborative, USG-interagency effort to rapidly respond to this continuously evolving public health emergency.

“Today’s request to revoke is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat COVID-19 [Coronavirus Disease 2019] and that the drug’s potential benefits for such use do not outweigh its known and potential risks.

“FDA has concluded that, based on this new information and other information discussed in the attached memorandum, it is no longer reasonable to believe that oral formulations of HCQ (hydroxychloroquine) and CQ (chloroquine) may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.

“Accordingly, FDA revokes the EUA for emergency use of HCQ and CQ to treat COVID-19, pursuant to section 564(g)(2) of the Act. As of the date of this letter, the oral formulations of HCQ and CQ are no longer authorized by FDA to treat COVID-19.”

The approval was given after President Donald Trump solicited the use of chloroquine for the treatment of the virus, despite warnings that there is little scientific evidence of the drug’s effectiveness.