FDA revokes emergency use authorization for chloroquine, hydroxychloroquine
The U.S. Food and Drug Administration (FDA) on Monday revoked the emergency use authorization (EUA) for chloroquine and hydroxychloroquine donated to the Strategic National Stockpile to treat certain hospitalized coronavirus patients, according to a new statement.
The FDA decided the legal criteria for issuing an EUA were “no longer met.”
Further, the FDA determined, based on ongoing analysis of the EUA and emerging scientific data, that the two drugs are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. While the drugs are deemed generally safe when prescribed for patients with malaria or an autoimmune disease, little was otherwise known about the potential effects they had in COVID-19 patients.
“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 …continued .
[Source: Fox News]