U.S. FDA revokes hydroxychloroquine emergency approval as a Covid-19 treatment

Jun 15, 2020 | 14 comments

By Lev Facher

The U.S.  Food and Drug Administration on Monday said it had withdrawn an emergency approval for use of the malaria drug hydroxychloroquine as a Covid-19 treatment.

Credit: George Frey / Getty Images

Almost since the beginning of the novel coronavirus pandemic, U. S. President Donald Trump and other world leaders have touted hydroxychloroquine as an effective treatment based on scattered anecdotes, not reliable scientific studies. But the FDA said Monday that the drug, along with chloroquine, is “unlikely to be effective in treating Covid-19,” and highlighted “serious side effects.”

The FDA’s withdrawal of the emergency use order, which Politico first reported, appears to formally close the door on U.S. officials’ willingness to use the drug to prevent or treat Covid-19, the disease caused by the novel coronavirus.

In recent weeks, an increasingly conclusive body of research showed the drug was not effective at treating Covid-19 or at preventing the respiratory disease from developing in individuals who’d been exposed to the virus.

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The controversy has pitted Trump and his high-profile allies against the country’s scientific establishment. Rick Bright, a prominent government scientist, has alleged he was ousted from his vaccine-development role after he opposed the initial emergency approval for hydroxychloroquine. At a March press conference, Trump said his belief in the drug was “just a feeling,” contradicting Tony Fauci, the country’s top infectious disease researcher, who told reporters minutes before there was no reliable evidence supporting hydroxychloroquine’s use.

Despite the lack of evidence supporting the drug’s use, Trump continued to tout it as a promising tool to treat and prevent Covid-19, even announcing last month that he had taken a regimen of hydroxychloroquine as a safeguard.

Asked for comment, an FDA spokesman directed STAT to an online list of current emergency use authorizations for Covid-19 medical products. The list no longer includes hydroxychloroquine.

In a letter to Gary Disbrow, the acting director of the Biomedical Advanced Research and Development Authority, a top FDA official said the withdrawal of the hydroxychloroquine approval was based on recent science that showed the drug to be ineffective.

“Today’s request to revoke is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat [Covid-19] and that the drug’s potential benefits for such use do not outweigh its known and potential risks,” wrote Denise Hinton, the FDA’s chief scientist.”

The FDA had previously expressed concerns about broad use of hydroxychloroquine, issuing a pointed warning in late April that cautioned against use of the drug outside the setting of a hospital or clinical trial.

While the hydroxychloroquine saga largely pitted politicians against scientists, the science underpinning the debate also proved, at times, surprisingly unreliable. Earlier this month, the Lancet, a leading medical journal, retracted an influential study that suggested hydroxychloroquine wasn’t just ineffective but also potentially unsafe for use as a Covid-19 treatment.

Nicholas Florko contributed reporting.
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