Tuesday 26 January 2021

FDA revokes authorization of drug Trump touted for Covid-19

WASHINGTON, June 15, 2020

The US Food and Drug Administration (FDA) has revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate to be used to treat certain hospitalised patients with Covid-19.
Hydroxychloroquine was frequently touted by US President Donald Trump and he has claimed to have used it himself.
FDA has determined that the legal criteria for issuing an EUA are no longer met, it said in a statement.
Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating Covid-19 for the authorised uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorised use, it said.
“We’ve made clear throughout the public health emergency that our actions will be guided by science and that our decisions may evolve as we learn more about the SARS-CoV-2 virus, review the latest data, and consider the balance of risks versus benefits of treatments for Covid-19,” said FDA Deputy Commissioner for Medical and Scientific Affairs Anand Shah, MD. 
“The FDA always underpins its decision-making with the most trustworthy, high-quality, up-to-date evidence available. We will continue to examine all of the emergency use authorizations the FDA has issued and make changes, as appropriate, based on emerging evidence.” - TradeArabia News Service


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