Emergency Use Authorization For Hydroxychloroquine, Drug Trump Used to Prevent Coronavirus, Repealed by FDA

The Food and Drug Administration (FDA) on Monday repealed its emergency use authorization (EUA) for hydroxychloroquine, a drug that has been used in the U.S. and around the world as a temporary treatment for COVID-19.

The FDA authorized an EUA for the drug earlier this year as the coronavirus pandemic was spreading across the U.S. Though the drug has appeared to ease the symptoms of COVID-19 in some patients, researchers have in recent weeks cautioned against the widespread use of the drug due to concerns over the side effects patients can experience after taking it.

"FDA has determined that [hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ)] are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA," the agency said in a statement on its website.

Hydroxychloroquine
A bottle and pills of Hydroxychloroquine sit on a counter at Rock Canyon Pharmacy in Provo, Utah, on May 20, 2020. On Monday, the FDA announced it was repealing its emergency use authorization for the drug. GEORGE FREY/AFP via Getty Images

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"In light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use."

Hydroxychloroquine is often prescribed by medical professionals to treat malaria and lupus. According to the U.S. Department of Health and Human Services (HHS), early studies into hydroxychloroquine and chloroquine, another anti-malaria drug that also received an EUA from the FDA, indicated both were effective in treating teenagers and adults who were hospitalized after contracting COVID-19. The EUA enabled medical professionals to dispense both drugs widely in spite of the fact that neither was a proven treatment for the novel coronavirus.

The use of hydroxychloroquine as a preliminary COVID-19 treatment received a bump from President Donald Trump shortly after the FDA allowed its temporary use. Last month, Trump told reporters he was taking the drug every day as a precaution against the virus, and several of his GOP allies also spoke in favor of taking the drug as a preventative measure.

Despite the hype surrounding hydroxychloroquine, data concerning its effectiveness began to sour as additional research was conducted into the side effects it had on COVID-19 patients. According to the FDA, some patients began experiencing heart rhythm problems after taking the drug. In response to these adverse effects, the FDA warned Americans in late April against taking hydroxychloroquine without consulting their doctors. One month later, the World Health Organization halted its hydroxychloroquine trial due to safety concerns, though the trial was allowed to resume in early June.

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In a letter sent Monday to Biomedical Advanced Research and Development Authority researchers at the HHS, the FDA said it was unable to consistently show that the drug had the antiviral properties that were essential to its initial approval for emergency use. Instead, some COVID-19 patients were diagnosed with a blood disorder called methemoglobinemia and experienced "serious cardiac adverse events" after taking the drug, the letter read.

The White House did not respond to Newsweek's request for comment in time for publication.

Though the drug is no longer approved for emergency use, the FDA said researchers studying the effectiveness of hydroxychloroquine in the treatment of COVID-19 can continue in the form of approved scientific trials.

This story has been updated with additional information and background.

Emergency Use Authorization For Hydroxychloroquine, Drug Trump Used to Prevent Coronavirus, Repealed by FDA | Health