Coronavirus: FDA revokes emergency use authorization for hydroxychloroquine

Officials with the U.S. Food and Drug Administration announced Monday that the agency has revoked an emergency authorization issued in March for an antimalarial drug touted by President Donald Trump as a possible treatment for COVID-19.

In a letter dated Monday, the FDA’s chief scientist, Denise Hinton, said the decision was made “based on new information, including clinical trial data results, that have led (the Biomedical Advanced Research and Development Authority) 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.”

>> Read the full letter from the FDA

Officials previously issued emergency use authorizations for hydroxychloroquine and a similar drug, chloroquine, allowing doctors to use the medicines to treat COVID-19 patients. Such authorizations are granted in serious or life-threatening cases in which "there is no adequate, approved, and available alternatives," to unapproved treatments, according to officials.

"(The) FDA has concluded that … it is no longer reasonable to believe that oral formulations of (hydroxychloroquine) and (chloroquine) may be effective for COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known or potential risks," Hinton said Monday.

Trump has dismissed concerns around the safety of hydroxychloroquine, which is typically used to prevent or treat malaria. He told reporters last month that he took a two-week course of the drug as a precaution to protect himself against a coronavirus infection. He said at the time that he had requested the treatment from the White House physician.

Last month, the World Health Organization announced it was pausing its multi-country Solidarity Trial of hydroxychloroquine in light of an observational study that found COVID-19 patients who were treated with hydroxychloroquine, chloroquine or a combination of either drug and an antibiotic were at a higher risk for death. Researchers later walked back the study due to issues verifying the data the study was based on.

Officials with the World Health Organization have since said they have resumed the study of hydroxychloroquine, according to CNN.

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