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News > U.S.

US: FDA Revokes Emergency Use Of Hydroxychloroquine

  • Hydroxychloroquine is an antimalarial drug that is also used for treating conditions like lupus or arthritis.

    Hydroxychloroquine is an antimalarial drug that is also used for treating conditions like lupus or arthritis. | Photo: AFP

Published 15 June 2020
Opinion

Emergency use authorization is designed to facilitate the availability of drugs needed during public health emergencies.

The United States Food and Drug Administration (FDA) Monday revoked the authorization for the emergency use of hydroxychloroquine (CHQ) to treat certain hospitalized patients with COVID-19 as a clinical trial is unavailable nor feasible.

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Study Confirms Chloroquine's Ineffectiveness in Facing COVID-19

On April 7, the FDA approved the emergency use for an abbreviated new drug application for hydroxychloroquine sulfate tablets to address ongoing shortages of the drug sparked by its still unproven potential as a COVID-19 treatment.

Emergency use authorization is designed to facilitate the availability of drugs needed during public health emergencies. It allows unapproved medical products or unapproved uses of approved medical products to be used in such emergencies.

However, now the FDA decided to revoke the authorization based on scientific data that determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 patients.

Furthermore, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use as the organization points out in the withdrawal letter.

"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 COVID-19," the organization said.

Hydroxychloroquine is an antimalarial drug that is also used for treating conditions like lupus or arthritis. Some medical research found that the patients were more likely to die in the hospital and develop heart complications than other COVID-19 patients who were not given the drug.

After U.S. President Donald Trump touted the use of the drug, Brazil's President Jair Bolsonaro backed the idea, and India's Prime Minister Narendra Modi lifted some restrictions to allow the exportation of CHQ pills.

Nevertheless, France, Italy, and Belgium stopped the use of the drug after safety concerns following a decision by the World Health Organization to stop a global trial of the drug.

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