FDA revokes emergency use authorisation for hydroxychloroquine

The US Food and Drug Administration (FDA) has revoked the emergency use authorisation (EUA) of the anti-malarial drugs chloroquine phosphate and hydroxychloroquine for the treatment of Covid-19.

The decision comes after the FDA reviewed emerging scientific data which indicate that neither of the drugs are likely to be effective in treating Covid-19. In particular, the FDA states that a large randomised clinical trial in hospitalised patients showed how the drugs offered no benefit for decreasing the likelihood of death or in speeding recovery.

The FDA granted EUA for both of the drugs in late March to treat hospitalised patients with Covid-19. Hydroxychloroquine had been highlighted by the World Health Organisation (WHO) as a targeted research priority for combatting Covid-19. Recent studies however have called into question the drugs’ effectiveness in helping treat Covid-19.

More so, the FDA’s decision comes based off data that show the drugs’ benefits no longer outweigh any potential risks. The drugs can cause serious heart rhythm problems in Covid-19 patients, particularly when used in combination with other medicines.

“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. “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 authorisations the FDA has issued and make changes, as appropriate, based on emerging evidence.”

Hydroxychloroquine received mass attention when US president Donald Trump said he was taking the anti-malarial drug to prevent Covid-19.