The U.S. Food and Drug Administration has revoked its emergency use authorisation for chloroquine and hydroxychloroquine as treatments for COVID-19. The U.K. Medicines and Healthcare products Regulatory Agency has followed suit, but Brazil criticised the decision and expanded the drugs’ use.
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The Food and Drug Administration (FDA) has stated that the controversial drugs were “unlikely to be effective in treating COVID-19.” Emergency use authorisation (EUA) allowed for donation of two malaria drugs to the Strategic National Stockpile to be used for treating those patients hospitalised with COVID-19 for whom a clinical trial was unavailable or unfeasible. The EUA withdrawal, as well as the original EUA back in March, was requested by the Biomedical Advanced Research and Development Authority.
The FDA also cited concerns about safety, particularly serious cardiac
events, saying that “the known and potential benefits of chloroquine and
hydroxychloroquine no longer outweigh the known and potential risks for the
authorized use.”
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has also
instructed
clinical trialists using hydroxychloroquine to treat or prevent COVID-19 to
suspend recruitment of further participants “until further data which justifies
[the trials’] continuation have been provided, and any additional safety
measures have been implemented.”
The European Medicines Agency has also warned
about the serious side effects that can result from treatment in COVID-19
patients with chloroquine and hydroxychloroquine as “their beneficial effects
in this patient population are not established.”
In April, the U.S. Centers for Disease Control and Prevention (CDC) removed
the guidance for using hydroxychloroquine as a potential treatment for the new
coronavirus.
A large study, published in The Lancet last month, found that
hydroxychloroquine associated with an increased risk of in-hospital mortality.
It prompted the World Health Organization (WHO) to pause the clinical trials of
the two drugs, and the French government to revoke authorising hospitals to
prescribe the drug for COVID-19 patients. However, the study has since then
been retracted
by the authors. WHO was reported to resume the trials, but on 17 June announced that they were being stopped. Last week the world’s largest
clinical trial of potential coronavirus treatments, the Randomised Evaluation
of COVID-19 Therapy trial (‘RECOVERY’)
released preliminary results showing no
effect on mortality from the use of hydroxychloroquine in patients admitted
to hospital with COVID-19.
By contrast, hours after the FDA’s decision Brazilian health authorities announced
that hydroxychloroquine would be recommended to use in children and pregnant
women for early treatment of COVID-19, and criticised the FDA’s approach, CNN reports.
"The studies referenced by the FDA today cannot be used as examples for
Brazil or for the rest of the world," Mayra Pinheiro, a Health Ministry
official said during the press conference claiming that the "quality of
their methodology is terrible."
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