US FDA withdraws emergency use of HCQ for treating coronavirus COVID-19 patients

The US Food and Drug Administration (FDA) on Monday (June 15)  withdrew the emergency use authorisation of anti-malarial drug hydroxychloroquine in the treatment of COVID-19 patients saying that the drug, which was called as 'game-changer' in treatment of COVID-19, may not be effective to cure the deadly virus infection.

The US food and drug regulatory body took the decision on the basis of some new information, including clinical trial data results. The US FDA also said that the benefits of HCQ in treating the COVID-19 patients do not outweigh its known risks.

FDA chief scientist Denise Hinton wrote a letter to Biomedical Advanced Research and Development Authority (BARDA) saying that the oral formulations of hydroxychloroquine (HCQ) and (chloroquine) CQ should not be used to treat COVID-19 patients.

It may be recalled that the emergency use authorization for use of oral formulations of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) was issued by the US FDA  on March 28, .

"Earlier observations of decreased viral shedding with HCQ or CQ treatment have not been consistently replicated and recent data from a randomised controlled trial assessing probability of negative conversion showed no difference between HCQ and standard of care alone," Hinton said in his letter.

Notably, as per the current treatment guidelines in the US, the use of CQ or HCQ is not recommended in hospitalised patients with COVID-19 outside of a clinical trial.

"Recent data from a large randomised controlled trial showed no evidence of benefit for mortality or other outcomes such as hospital length of stay or need for mechanical ventilation of HCQ treatment in hospitalised patients with COVID-19," the letter said.

Earlier, President Trump had called HCQ a "game-changer" drug in the fight against COVID-19 and at his request India had allowed the export of 50 million HCQ tablets to the US in April.

On May 18, Trump had said in a press conference that he was taking hydroxychloroquine daily to keep himself safe from coronavirus. He had also called hydroxychloroquine a "line of defence" against the 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 no impact from it," Trump had said.