COVID-19 News

FDA withdraws EUA for hydrochloriquine therapy for COVID-19

The Food and Drug Administration said Monday that it was revoking emergency authorization of two malaria drugs to treat Covid-19, saying that they are “unlikely to be effective.”

The drugs, hydroxychloroquine and a related drug, chloroquine, were heavily promoted by President Trump after a handful of small, poorly controlled studies showed that they could work in treating the disease.

Mr. Trump even took hydroxychloroquine after he was exposed to two people who had tested positive for the coronavirus. The agency said that after reviewing some data, it had determined that the drugs, particularly hydroxychloroquine, did not demonstrate benefits that outweighed their risks. Earlier this year, the F.D.A. had also issued a warning that the drugs could cause alarming heart arrhythmias.

In March, the F.D.A. authorized stockpiles of the drugs to be used in hospitals to treat patients with the virus. But in a letter Monday revoking the authorization, the agency said that further studies have shown that the two drugs were unlikely to be effective in stopping the virus, and that current national treatment guidelines don’t recommend using them outside of clinical trials.

According to the letter, written by Denise M. Hinton, the F.D.A.’s chief scientist, the request to revoke the authorization came from the Biomedical Advanced Research and Development Authority, a unit of the Department of Health and Human Services that is in charge of supplying treatments in public health emergencies.

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