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FDA Revokes Emergency Use of Chloroquine Phosphate, Hydroxychloroquine Sulfate

New Jersey

On Monday, The FDA revoked the emergency use authorization (EUA) that allowed for chloroquine phosphate and hydroxychloroquine sulfate donated to the Strategic National Stockpile to be used to treat certain hospitalized patients with COVID-19 when a clinical trial was unavailable, or participation in a clinical trial was not feasible according to a statement released by the agency.

FDA officials said, based on its ongoing analysis of the EUA 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.

According to the press release from the FDA, in light of ongoing cardiac severe adverse events and other potentially dangerous side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.

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