FDA revokes emergency use authorization for chloroquine, hydroxychloroquine treatment coVID-19
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Last Update: 2020-06-24
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Source: Internet
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Author: User
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The FDAtoday revoked the emergency use authorization (EUA) for theCOVID-19, the antimalarial drugs chloroquine and hydroxychloroquineThe FDA said the latest data, including clinical trial results, showed that the drugs "may not be effective in treating COVID-19."The FDA noted that these drugs are still authorized for use in emergencies to continue treatment of COVID-19 inpatients in public health emergencies, as long as the patient's attending physician deems it necessaryThe FDA said it had negotiated with the U.SBureau of Advanced Biomedical Research and Development (BARDA) to withdraw the EUAIn its decision, the FDA said agency reviewers re-evaluated the literature studies on which chloroquine and hydroxychloroquine were used to obtain EUA and highlighted the limitations of those studiesSpecifically, the new analysis shows that the dosing regimen in EUA is unlikely to have an antiviral effect, and that the dose required for antiviral action increases unacceptable toxicityThe agency also cited the latest results of the RECOVERY trial being conducted at Oxford University, which showed that hydroxychloroquine had no benefit to the mortality or other outcomes of COVID-19 hospitalizations, such as hospital stay or mechanical ventilation time
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