The US FDA Has Revoked the Emergency Use Authorizations (EUA) of Chloroquine and Hydroxychloroquine to Treat COVID-19
The US FDA Has Revoked the Emergency Use Authorizations (EUA) for emergency use of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) to treat the COVID-19 disease because BARDA concluded, based on clinical trial data results, that the drug’s potential benefits do not outweigh its known and potential risks.
These two drugs were touted by President Donald Trump and others via Twitter below.
HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine. The FDA has moved mountains – Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents)…..— Donald J. Trump (@realDonaldTrump) March 21, 2020
Pursuant to the sections 564, 564(g)(2), 564(b)(1), or 564(c) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3), the authorization of a product for emergency use may be revised or revoked.
The FDA has determined that the criteria under section 564(c) of the Act for issuance of the EUA referenced above are no longer met. Under section 564(c)(2) of the Act, an EUA may be issued only if FDA concludes “that, based on the totality of scientific evidence available to the Secretary, ncluding data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that: (A) the product may be effective in diagnosing, treating, or preventing—(i) such disease or condition [….]; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product […].”
It is concluded by FDA that these criteria are no longer met based on the following criteria:
- We now believe that the suggested dosing regimens for CQ and HCQ as detailed in the Fact Sheets are unlikely to produce an antiviral effect.
- Earlier observations of decreased viral shedding with HCQ or CQ treatment have not been consistently replicated and recent data from a randomized controlled trial assessing probability of negative conversion showed no difference between HCQ and standard of care alone.
- Current U.S. treatment guidelines do not recommend the use of CQ or HCQ in hospitalized patients with COVID-19 outside of a clinical trial, and the NIH guidelines now recommend against such use outside of a clinical trial.
- Recent data from a large randomized controlled trial showed no evidence of benefit for mortality or other outcomes such as hospital length of stay or need for mechanical ventilation of HCQ treatment in hospitalized patients with COVID19.
Read a full letter addressed to the following here >>
Gary L. Disbrow Ph.D.
Deputy Assistant Secretary
Director, Medical Countermeasure Programs
Biomedical Advanced Research and Development Authority (BARDA)
Office of Assistant Secretary for Preparedness and Response (ASPR)
U.S. Department of Health and Human Services (HHS)
330 Independence Ave, S.W., Room 640G
Washington, D.C. 20201
Download FDA’s revocation of the EUA for the HCQ and CQ for the treatment of COVID-19.
Last Updated: 2020-06-15
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