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FDA revokes EUA for hydroxychloroquine, chloroquine

Posted 15 June 2020 | By Michael Mezher 

FDA revokes EUA for hydroxychloroquine, chloroquine

The US Food and Drug Administration (FDA) on Monday revoked the emergency use authorization (EUA) allowing the use of chloroquine phosphate and hydroxychloroquine sulfate to treat hospitalized patients with coronavirus disease (COVID-19) at the request of the Biomedical Advanced Research and Development Authority (BARDA).
“Today’s request to revoke is based on new information, including clinical trial data results, that have led BARDA 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,” FDA writes in its letter revoking the EUA, which was first issued in late March.
FDA’s decision to issue the EUA for hydroxychloroquine and chloroquine was controversial, prompting questions about the agency’s standards and political independence, and much of the public debate over the use of the drugs was highly politically charged. (RELATED: Harvard professors call on FDA to maintain review standards amid COVID-19, Regulatory Focus 15 April 2020).
While the decision cuts off further distribution of hydroxychloroquine and chloroquine from the strategic national stockpile, FDA notes that any of the drugs that have already been distributed under the EUA may be used to continue treatment in patients who are currently being treated with the drugs.
FDA adds that the hydroxychloroquine products covered under the EUA are approved for other uses and may continue to be distributed commercially, though the chloroquine product authorized under the EUA was not FDA-approved. The agency also notes that other chloroquine products are approved to treat malaria, and approved versions of both drugs may be prescribed for off-label use at the discretion of a physician.
FDA further explains that it does not believe the dosing levels described in the EUA are likely to produce an antiviral effect and that recent studies have failed to replicate earlier results showing decreased viral shedding in patients treated with the drugs.
Additionally, FDA says that a recent randomized controlled trial “showed no evidence of benefit for mortality or other outcomes such as hospital length of stay or need for mechanical ventilation,” and that outcome data reported to BARDA on the drugs’ use has been lacking, with “few reports” submitted to date.


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