The Food and Drug Administration announced Monday (June 15) that it is revoking emergency use authorization for both hydroxychloroquine and chloroquine—two antimalarial drugs that were initially indicated as a treatment for COVID-19—amid a number of studies that have since shown potentially deadly side effects.
In a statement by Denise Hinton, the FDA’s chief scientist, she notes that the drugs’ unproven benefits are not offset by their “known and potential risks.”
Both medications saw a rush in demand beginning in late March after President Donald Trump touted their use. But one month later, the FDA released a safety warning detailing heart risks linked to the drugs. A series of subsequent studies cast doubt on the medications’ ability to either dampen symptoms or speed recovery, suggesting instead that they may actively cause harm. (Some of the most damning evidence against hydroxychloroquine was discredited upon high-profile retractions of the published studies.) Data analyzed by the FDA in the course of making its decision identified more than 100 instances of serious heart disorders in COVID-19 patients, of which 25 were fatal, The New York Times reports.
“There has never been any high-quality evidence suggesting that hydroxychloroquine is effective,” Steven Nissen, a cardiologist at the Cleveland Clinic who has previously advised the FDA, says in an interview with the Associated Press. He adds that the FDA should never have granted emergency authorization in the first place given that evidence supports the claims of harmful side effects.
The FDA’s decision doesn’t mean the drugs will be pulled from the market. Doctors can still prescribe them to patients “off label” to treat conditions other than those included in the original FDA approval, according to Science. In addition, the National Institutes of Health (NIH) has voiced its intention to move forward with clinical trials for COVID-19.
“I think that would be unfortunate not to,” Francis Collins, director of the NIH, tells The New York Times. “What’s been missing here are really well-designed, randomized placebo-controlled trials for hospitalized patients.” The World Health Organization is reassessing its trials of both medications and plans to release a statement today, according to Science.
The FDA also released another warning on Monday about pairing either hydroxychloroquine or chloroquine with remdesivir, which was granted emergency use authorization as a COVID-19 treatment in May. Research suggests the antimalarial drugs may interact poorly with remdesivir, weakening its benefits in shortening the duration and severity of coronavirus infections.