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FDA Revokes Emergency Authorization For Hydroxychloroquine To Treat COVID-19

drug aug15 16jun20 lt

The Food and Drug Administration revoked its emergency authorization for hydroxychloroquine as an alternative treatment for coronavirus amid safety concerns.

In March, FDA had given emergency use authorization for two malaria drugs — chloroquine and hydroxychloroquine — for the treatment of hospitalized severe COVID-19 patients.

The US federal agency said in a statement that clinical trials have shown that hydroxychloroquine was ineffective in treating the deadly virus, and that it is no longer reasonable to believe it will prevent infection.

Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA.

Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use, FDA said in the statement.

The Biomedical Advanced Research and Development Authority (BARDA) had sent a letter to the FDA requesting revocation of the emergency use authorization.

The fact sheet for patients and caregivers was also updated to include additional information about possible allergic reactions and to alert patients to tell their healthcare providers if they are taking chloroquine phosphate or hydroxychloroquine sulfate.

The United States and some other countries are using Hydroxychloroquine as a life-saving measure against the coronavirus, but there is no conclusive scientific evidence that the tablets can cure the infection from the novel pathogen.

The World Health Organization has suspended trials of hydroxychloroquine as a possible treatment for coronavirus amid safety concerns.

A study in The Lancet underrated the benefits of hydroxychloroquine in treating coronavirus patients.

According to the report in the medical journal, it might even prove dangerous than as a cure for the disease.

President Donald Trump, who had repeatedly touted hydroxychloroquine as effective in the treatment of the deadly disease, had completed taking a two-week course of the medicine.

Responding to the FDA's decision, Trump told reporters, "I took it and I felt good about taking it. I can't complain about it, I took it for two weeks, and I'm here, here we are."

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