After Donating Two Million Chloroquine Doses to Brazil, USA Revokes Use Permission
RIO DE JANEIRO, BRAZIL – US health authorities announced on Monday the decision to overturn “the authorization for emergency use allowing chloroquine phosphate and hydroxychloroquine sulfate to be used to treat some hospitalized patients with COVID-19” outside clinical trials. Now, for the drug to enter the country’s health protocol, the full scientific tests will need to be awaited and emergency use will no longer be allowed.
This week, the WHO announced that it will also decide whether or not to continue testing the drug. The world agency has been conducting tests on the product.
The drug used for the treatment of malaria had been one of the hopes in the case of coronavirus. But according to the WHO, so far there is no scientific evidence that it can produce benefits.
Two million doses to Brazil
In recent weeks, the Brazilian government celebrated the White House’s decision to allocate two million doses of the drug to Brazil, while Jair Bolsonaro’s advisor, Arthur Weintraub, suggested that the Nuremberg court be convened against those who refused to prescribe the drug.
But on Monday, the US Food and Drug Administration (FDA) “ruled that the legal criteria for issuing an emergency use authorization are no longer satisfied.” The FDA is a branch of the US Department of Health and Human Services.
Brazil’s Foreign Office (Itamaraty) has not yet announced whether or not the donation will be maintained.
“Based on its continued testing and emerging scientific data, the FDA has determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for its authorized applications in the US,” said the American health regulator.
“In addition, in light of ongoing serious cardiac events and other potentially serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for its authorized use,” it said.
The authorization for the emergency use of the drug had been granted on March 28th, 2020 “based on science and data available at the time”. The decision then provided that the product should only be administered with medical follow-up and within clinics for the most critical patients.
Science-driven
“We have made it clear throughout the public health emergency that our actions will be science-driven and that our decisions may evolve as we learn more about the SARS-CoV-2 virus, review the latest data and consider the balance between risks and benefits of treatments for COVID-19,” said Anand Shah, Assistant Commissioner for Medical and Scientific Affairs at the FDA.
“The FDA always supports its decisions with the most reliable, high-quality, and up-to-date evidence available. We will continue to review all emergency use authorizations the FDA has issued and amend as appropriate based on emerging evidence,” he said.
“While additional clinical studies continue to assess the potential benefit of these drugs in the treatment or prevention of COVID-19, we decided that the emergency use authorization was no longer appropriate. This action was taken after rigorous evaluation by scientists at our Center for Drug Evaluation and Research,” said Patrizia Cavazzoni, acting director of the FDA Center for Drug Evaluation.
Source: UOL
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