US revokes emergency use of drugs touted by Trump vs. virus

WASHINGTON — U.S. regulators on 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, and can cause heart rhythm problems, severely low blood pressure and muscle or nerve damage. The agency 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.

FDA’s move means that 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.