FDA withdraws hydroxychloroquine for emergencies 0:49
. – The US Food and Drug Administration revoked its emergency use authorization for the drugs hydroxychloroquine and chloroquine for the treatment of covid-19.
After reviewing the current available research on the drugs, the FDA determined that the drugs do not meet “the legal criteria” for emergency use authorization, as they are unlikely to be effective in treating covid-19 according to the Latest scientific evidence, the agency noted on its website on Monday.
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“The FDA has concluded that, based on this new information and other information discussed in the accompanying memorandum, it is no longer reasonable to believe that oral formulations of HCQ and CQ can be effective in treating covid-19, nor is it reasonable to believe “The known and potential benefits of these products outweigh their known and potential risks,” FDA Chief Scientist Denise Hinton wrote Monday in a letter to Gary Disbrow of the Advanced Biomedical Research and Development Authority (BARDA).
“Accordingly, the FDA revokes the authorization for the emergency use of HCQ and CQ to treat covid-19,” Hinton wrote in the letter. “As of the date of this letter, the oral formulations of HCQ and CQ are no longer authorized by the FDA to treat covid-19.”
The FDA emergency use authorization for hydroxychloroquine and chloroquine was limited in scope, applied only to hospitalized patients with covid-19 and only to medications donated to the Strategic National Reserve.
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In an open letter published late last month, FDA Commissioner Dr. Stephen Hahn appeared to defend the agency’s decision to issue the authorization.
“This decision was based on the evaluation of the EUA criteria and the scientific evidence available at the time. We are continuing to analyze the data on hydroxychloroquine and chloroquine and will make future determinations on these products based on the available evidence, including ongoing clinical studies, “Hahn said in the letter last month.
The emergency use authorization, or USA, facilitated the distribution of the donated pills to the national reserve to patients with coronavirus.
Hahn added in the letter, “We also knew that it was important to help ensure a stable supply of the drugs for patients with lupus and rheumatoid arthritis given the increased demand.”
In an interview with CNN last month, Hahn also defended his agency’s handling of hydroxychloroquine. He acknowledged the political climate surrounding the drug, but said: “I support our decisions because I believe they are based on science and data, and we will continue to reevaluate.”