FDA revokes coronavirus emergency authorization for Trump-touted hydroxychloroquine
A drug touted by President Donald Trump as a coronavirus treatment has had its emergency use authorization revoked by the U.S. Food & Drug Administration.
Chloroquine and hydroxychloroquine “are unlikely to produce an antiviral effect” in coronavirus treatment, an FDA chief scientist wrote in a letter to the agency’s top official on Wednesday. The drugs were being used for patients hospitalized with COVID-19 and in clinical trials.
The potential benefits of the drugs do not “outweigh their known and potential risks,” chief scientist Denis M. Hinton said in the letter to Dr. Gary L. Disbrow.
Revoking the drugs’ emergency use means they are no longer federally authorized to treat COVID-19.
The FDA said in April the drugs were not shown to be safe in treating or preventing COVID-19.
Trials began with 500 adults in April, by the National Institutes of Health. The organization now recommends not using the drugs other than in a clinical trial, according to the FDA.
The Lancet, one of the world’s top medical journals, retracted a major study earlier this month on hydroxychloroquine after the authors were unable to “vouch for the veracity of the primary data sources.’”
Trump has touted hydroxychloroquine, saying in a White House press briefing in April “we hear great results” about it. He also said in a tweet the drug could be “one of the biggest game changers in the history of medicine” when taken with azithromycin, an antibiotic commonly known as a Z-pack.
Trump said in May he had been taking the drug along with zinc as a way to prevent COVID-19.
“I think it gives you an additional level of safety,” he said at the time, according to The Hill.
Some critics said the FDA caved to political pressure to authorize the emergency use of the drugs, according to Politico.
Hydroxychloroquine is often used to treat malaria and arthritis. The end of the drug’s emergency use for coronavirus treatment will not change its use for other treatments.
The drug’s risks can include “cardiac arrhythmias, seizures, dermatological reactions and hypoglycemia,” according to the National Institutes of Health.
