The United States Food and Drug Administration (FDA) announced today that it has revoked the previously issued Emergency Use Authorization (US) for antimalarial drugs hydroxychloroquine and chloroquine for the treatment of COVID-19, saying the medications They no longer met the Legal Criteria for Emergency Use.
The agency said on its website that, based on its review of the scientific evidence available for the drugs, hydroxychloroquine and chloroquine "are not likely to be effective in treating COVID-19 for authorized uses in the US." The FDA also said that due to serious cardiac events and other side effects associated with the two drugs, the potential benefits no longer outweigh the risks.
The FDA made the decision in consultation with the Advanced Biomedical Research and Development Authority (BARDA), which had originally requested the EUA.
The measure comes less than 3 months after the FDA issued the EUA, which allowed hydroxychloroquine and chloroquine to be donated to the National Strategic Reserve and used in adult hospitalized patients with COVID-19, despite the lack of evidence of efficacy. The initial hope that the drugs could help COVID-19 patients was based on a small French study that found that they were associated with reduced viral load in a small number of patients when combined with the antibiotic azithromycin.
Widespread use, but no benefits shown
Since the US was issued, thousands of patients in the United States have been treated with hydroxychloroquine and chloroquine in hospitals. And President Donald Trump, who promoted the drugs, said in May that his doctor had prescribed hydroxychloroquine to prevent infection.
But several observational studies have found no benefit in patients with COVID-19 in terms of reduced deaths or more severe disease outcomes, such as the need for intubation or intensive care. Some studies have also found that the use of hydroxychloroquine and chloroquine is associated with an increased risk of serious heart rhythm complications in some patients. As a result, current treatment guidelines in the US do not recommend the use of medications in hospitalized patients with COVID-19 outside of a clinical trial.
Furthermore, the recent results of two enthusiastically controlled randomized clinical trials, which are considered the gold standard for evaluating the effectiveness of medical treatment, found that hydroxychloroquine and chloroquine did not reduce mortality in hospitalized patients with COVID-19 in the The United Kingdom did not prevent COVID-19 in American and Canadian volunteers exposed to infected patients compared to placebo.
In a letter to BARDA, FDA Chief Scientist Rear Admiral Denise Hinton said that, based on her review of this new information, the FDA had concluded that the suggested dosage regimens for hydroxychloroquine and chloroquine are unlikely to produce an antiviral effect. The observation of decreased viral clearance associated with medications has not been consistently replicated and there is no evidence of a benefit for death or other outcomes.
"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 the oral formulations of HCQ [hydroxychloroquine] and CQ [chloroquine] can be effective in the treatment of COVID- 19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks, "wrote Hinton.
The agency said that any hydroxychloroquine and chloroquine that has already been distributed to hospitals under the EUA is still licensed for emergency use in patients with COVID-19 and that patients currently receiving drug treatment can complete their courses of treatment. Clinical trials studying drugs for the treatment and prevention of COVID-19 will continue.
Mike Ryan, MD, head of the World Health Organization (WHO) health emergencies program, said today at a WHO press conference that a review board overseeing large multinational randomized controlled clinical trials to study treatments COVID-19 will meet this week to see the usefulness of continuing certain weapons of judgment. Hydroxychloroquine is one of the drugs under study in the SOLIDARITY trial.
In late May, the trial review board stopped the hydroxychloroquine arm to look for safety signs, but on June 3 allowed work to resume after none were found.
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