US FDA withdraws emergency use authorisation of chloroquine and hydroxychloroquine

US food and drug regulatory body on Monday withdrew emergency use authorisation of anti-malarial drugs chloroquine and hydroxychloroquine in treatment of COVID-19 patients after concluding that y may t be effective to cure virus infections.

Food and Drug Administration (FDA) said its decision is based on new information, including clinical trial data results, that have led it to conclude that drugs may t be effective to treat COVID-19 and that its potential benefits for such use do t outweigh its kwn and potential risks.

FDA chief scientist Denise Hinton, in a letter dated June 15 to Gary Disbrow of Biomedical Advanced Research and Development Authority (BARDA), said as of date of this letter, oral formulations of hydroxychloroquine (HCQ) and (chloroquine) CQ are longer authorised by FDA to treat COVID-19.

On March 28, FDA had issued emergency use authorization (EUA) for use of oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) to be distributed from Strategic National Stockpile (SNS).

Hinton said that FDA w believes that suggested dosing regimens for CQ and HCQ are unlikely to produce an antiviral effect.

“Earlier observations of decreased viral shedding with HCQ or CQ treatment have t been consistently replicated and recent data from a randomised controlled trial assessing probability of negative conversion showed difference between HCQ and standard of care alone,” he said.

Current US treatment guidelines do t recommend use of CQ or HCQ in hospitalised patients with COVID-19 outside of a clinical trial, and NIH guidelines w recommend against such use outside of a clinical trial, FDA said.

“Recent data from a large randomised controlled trial showed evidence of benefit for mortality or or outcomes such as hospital length of stay or need for mechanical ventilation of HCQ treatment in hospitalised patients with COVID-19,” letter said.

Hinton said that while HCQ, that has been distributed from SNS, is longer authorised under EUA to treat hospitalised patients for COVID-19, FDA-approved HCQ can be distributed in interstate commerce.

Hydroxychloroquine is one of oldest and best-kwn anti-malarial drugs. US President Donald Trump had called hydroxychloroquine a "game-changer" drug in fight against COVID-19.

At Trump's request, India in April allowed export of 50 million HCQ tablets to treat COVID-19 patients in America, worst-hit country by pandemic.

Trump had on May 18 disclosed that he was taking hydroxychloroquine daily to ward off deadly coronavirus.

Defending drug, he had said that hydroxychloroquine was a "line of defence" against coronavirus.

“It is a very powerful drug I guess but it doesn't harm you and so I thought as a frontline defence, possibly it would be good, and I have had impact from it," Trump had said, adding that antimalaria drug has received tremendous reviews from doctors all over world.

According to Johns Hopkins University data, US has over 2.1 million COVID-19 cases with more than 115,000 deaths.