FDA Withdraws Emergency Authorization For Hydroxychloroquine As COVID Treatment
The Food and Drug Administration withdrew its emergency use authorization for two drugs President Donald Trump has touted as treatments for COVID-19 due to serious safety concerns, according to The Hill.
The FDA pointed to recent clinical trial failures as evidence that “chloroquine and hydroxychloroquine may not be effective at treating COVID-19 or preventing it in people who have been exposed, and that their potential benefits do not outweigh the risks.”
The agency previously allowed the drugs’ use for hospitalized patients and in clinical trials, despite doctors’ warnings that they can cause serious heart problems.
In April, “the agency warned against using hydroxychloroquine outside of hospitals and clinical trials because of the risk of potentially fatal cardiac problems.”
The FDA noted in repealing the authorization “that recent data from a large randomized controlled trial showed no difference between using hydroxychloroquine and standard COVID treatment alone,” The Hill reported.
However, because the drugs are on the market and approved for other uses, it could still be prescribed for "off-label" use in COVID patients. Clinical trials studying the drugs can also continue. The World Health Organization and the National Institutes of Health are still conducting trails.
Trump began promoting hydroxychloroquine earlier this year, despite no scientific evidence supporting its use.
The president claimed last month that he was taking the drug himself, “in combination with zinc, as a way to prevent getting COVID-19 after a White House aide was diagnosed with the disease.”
“I think it gives you an additional level of safety,” Trump said at the time, downplaying the warnings that the drug can cause significant heart problems.
The Hill noted that the Trump “administration's embrace of hydroxychloroquine allegedly led to the ouster of Rick Bright, who led the Biomedical Advanced Research and Development Authority (BARDA) and oversaw federal efforts to find a vaccine and treatment for the coronavirus.”
The FDA’s move to revoke the emergency use authorization reportedly came after Bright’s successor, Gary Disbrow, made the request.