[WN]- The US Food and Drug Administration (FDA) on Monday (June 15) withdrew the emergency use authorization 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 randomized controlled trial assessing the 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 hospitalized patients with COVID-19 outside of a clinical trial.
"Recent data from a large randomized 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 hospitalized 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 defense" against the coronavirus.
"It is a very powerful drug I guess but it doesn't harm you and so I thought as a frontline defense, possibly it would be good, and I have had no impact from it," Trump had said.
The drug can still be used with a doctor's prescription, Azar noted. Any drug with U.S. approval can be used in any way a doctor sees fit regardless of what it has been approved for.
Drug's Use Already in Decline:
Doctors in recent weeks had already pulled back on the use of hydroxychloroquine for COVID-19 after several studies suggested it is not effective and may pose heart risks for certain patients.
The Infectious Diseases Society of America on Monday backed the FDA decision "to revoke emergency use authorization for hydroxychloroquine and chloroquine."
Half of the hospitals responding to a mid-May survey conducted by the American Society of Health-System Pharmacists (ASHP) reported excess supplies of hydroxychloroquine that they expected to return to wholesalers.
Current US government treatment guidelines do not recommend its use for COVID-19 patients outside of a clinical trial.
France, Italy, and Belgium late last month halted the use of hydroxychloroquine for COVID-19 patients. But the United States last month sent 2 million doses to Brazil, which has emerged as the pandemic's latest epicenter.
Hundreds of trials testing hydroxychloroquine or chloroquine as interventions for COVID-19 are still underway, including a U.S. study designed to show whether hydroxychloroquine in combination with azithromycin can prevent hospitalization and death from COVID-19.
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