Medpage Today
HCQ No Longer Approved Even a Little for COVID-19
— Study after study showed no benefit, and now the FDA has had enough
by Molly Walker, Associate Editor, MedPage Today June 15, 2020
The FDA rescinded its emergency use authorization (EUA) of hydroxychloroquine (HCQ) to treat COVID-19 patients, citing concerns about efficacy and risks associated with its use, and saying the drug no longer meets the criteria for an EUA, the agency said on Monday.
"The agency determined that the legal criteria for issuing an EUA are no longer met," according to an FDA statement. Both hydroxychloroquine and a related antimalarial drug, chloroquine (CQ), are "unlikely to be effective at treating COVID-19" for uses described in the EUA, the statement continued.
Moreover, the FDA now says the benefits of the drug "no longer outweigh the potential risks," citing the serious cardiac adverse events associated with the drug.
"This warrants revocation of the EUA for HCQ and CQ for the treatment of COVID-19," the agency said.
A letter from the agency to the Biomedical Advanced Research and Development Authority (BARDA) detailed the FDA's concerns, including that suggested dosing regimens are "unlikely to produce an antiviral effect," and said "decreased viral shedding" from treatment with these drugs, noted in some observational studies, "has not been consistently replicated."
HCQ No Longer Approved Even a Little for COVID-19 | MedPage Today