FDA Revokes Emergency Use Status Of Malaria Drug Used To Treat COVID-19

By Bill Galluccio

June 15, 2020

The U.S. Food and Drug Administration has revoked the emergency use authorization for the malaria drug hydroxychloroquine as a treatment for COVID-19. The FDA said that after reviewing several studies of the drug, they found little evidence that it was an effective treatment for the coronavirus.

"Based on its ongoing analysis of the [emergency use authorization (EAU)] and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use," the FDA said in a statement.

Researchers are continuing to study the effectiveness of the drug in treating patients with COVID-19, and the FDA said they will continue to monitor the progress of the studies.

"While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate. This action was taken following a rigorous assessment by scientists in our Center for Drug Evaluation and Research," said Patrizia Cavazzoni, M.D., acting director of the FDA's Center for Drug Evaluation.

President Donald Trump had previously touted the drug as a potential treatment and told the press he had taken the medication to prevent getting infected.

Photo: Getty Images

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