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FDA Pulls Emergency Approval of Hydroxychloroquine for COVID-19

Agency now says the drugs should not be used outside of clinical trials

MONDAY, June 15, 2020 (HealthDay News) -- The U.S. Food and Drug Administration has withdrawn its emergency authorization for the use of chloroquine phosphate and hydroxychloroquine sulfate in the fight against COVID-19.

The agency said in a letter Monday that the drugs are "unlikely to be effective" as treatments for COVID-19. The FDA now says the drugs should not be used outside of clinical trials.

Despite its earlier cautious approval, this is not the first time the agency has voiced concern about the experimental medicines. The FDA had already issued a warning that they might cause dangerous heart rhythm abnormalities. The FDA in March sanctioned use of the drugs in hospitals to treat COVID-19 patients. But after reviewing data on the drugs, the FDA has now concluded that the risks of taking them outweigh any benefit.

FDA chief scientist Denise Hinton said in the letter that the Biomedical Advanced Research and Development Authority had asked that the drugs' authorization for COVID-19 treatment be revoked. The authority is a division of the U.S. Department of Health and Human Services that oversees treatments in public health emergencies.

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