The Food and Drug Administration withdrew the emergency use authorization for hydroxychloroquine and chloroquine tablets as oral coronavirus treatments Monday.
“Today’s request to revoke is based on new information, including clinical trial data results, that have led [Biomedical Advanced Research and Development Authority] BARDA to conclude that this drug may not be effective to treat COVID-19 [Coronavirus Disease 2019] and that the drug’s potential benefits for such use do not outweigh its known and potential risks,” FDA’s chief scientist RADM Denise M. Hinton wrote in a letter to BARDA’s Deputy Assistant Secretary Gary Disbrow. “We now believe that the suggested dosing regimens for CQ and HCQ as detailed in the Fact Sheets are unlikely to produce an antiviral effect.” (RELATED: Why Did Two Medical Journals Retract Their Hydroxychloroquine Studies?)
“FDA has concluded that, based on this new information and other information discussed in the attached memorandum, it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks,” Hinton continued. “As of the date of this letter, the oral formulations of HCQ and CQ are no longer authorized by FDA to treat COVID-19.”
Monday’s action only applies to distribution of HCQ and CQ from the Strategic National Stockpile (SNS), as both drugs are approved for other uses by the FDA. Doctors are still allowed to prescribe both as off-label coronavirus treatments, and clinical trials on the drugs’ efficacy as coronavirus therapies will be allowed to continue.
WASHINGTON, DC – MAY 05: U.S. President Donald Trump talks to journalists as he departs the White House May 05, 2020 in Washington, DC. Trump is traveling to Phoenix, Arizona to tour a Honeywell International’s face mask production operation, which has increased manufacturing capabilities of N95 respirators in response to the novel coronavirus pandemic. (Photo by Chip Somodevilla/Getty Images)
President Donald Trump has repeatedly urged doctors to prescribe HCQ to treat coronavirus, and he himself — as confirmed in his latest White House physical — took HCQ as a coronavirus preventative back in May.
The White House declined to comment on Monday’s news and instead directed the Daily Caller to Hinton’s letter.