FDA revokes emergency use of drugs touted by Trump
WASHINGTON — U.S. regulators Monday revoked emergency authorization for malaria drugs promoted by President Donald Trump for treating COVID-19 amid growing evidence they don’t work and could cause serious side effects.
The Food and Drug Administration said the drugs hydroxychloroquine and chloroquine are unlikely to be effective in treating the coronavirus. Citing reports of heart complications, the FDA said the drugs’ unproven benefits “do not outweigh the known and potential risks.”
In a separate announcement, the FDA also warned doctors against prescribing the drugs in combination with remdesivir, the lone drug currently shown to help patients with COVID-19. The FDA said the anti-malaria drugs can reduce the effectiveness of remdesivir, which
FDA cleared for emergency use in May.
Hydroxychloroquine and chloroquine are frequently prescribed for lupus and rheumatoid arthritis but can cause heart rhythm problems, severely low blood pressure, and muscle or nerve damage. The FDA reported Monday that it had received nearly 390 reports of complications with the drugs, including more than 100 involving serious heart problems. Such reports represent an incomplete snapshot of complications with the drugs because many side effects go unreported.
The FDA’s move means shipments of the drugs obtained by the federal government will no longer be distributed to state and local health authorities for use against the coronavirus. The decades-old drugs are still available for alternate FDA-approved uses, so U.S. doctors could still prescribe them for COVID-19 — a practice known as off-label prescribing.
Dr. Steven Nissen, a Cleveland Clinic researcher who has been a frequent FDA adviser, agreed with the decision and said he would not have granted emergency access in the first place.
“There has never been any high-quality evidence suggesting that hyrdoxychloroquine is effective” for treating or preventing coronavirus infection, he said, but there is evidence of serious side effects.
On Thursday, a National Institutes of Health panel of experts revised its recommendations to specifically recommend against the drug’s use except in formal studies.
Mr. Trump aggressively pushed hydroxychloroquine beginning in the first weeks of the outbreak and stunned medical professionals when he declared that he had been taking the drug as a pre-emptive action against infection. After Mr. Trump’s repeated promotions, prescriptions for hydroxychloroquine soared, contributing to shortages.
No large, rigorous studies have found the drugs safe or effective for preventing or treating COVID-19, and a string of recent studies made clear they could do more harm than good.
Dr. Peter Lurie, a former FDA associate commissioner and an Obama administration appointee, said the agency had tarnished its reputation by clearing the drugs based on scant evidence and under apparent political pressure.
“This is an agency that gains its credibility from the strength of its scientific pronouncements,” said Dr. Lurie. “The lesson of this whole tawdry episode is that it’s the old painstaking ways of science that ultimately deliver safe and effective therapies.”