Matthew Perrone, The Associated Press
U.S. regulators 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 Monday, June 15.
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.”
The decades-old drugs, also prescribed for lupus and rheumatoid arthritis, can cause heart rhythm problems, severely low blood pressure and muscle or nerve damage.
The 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 drugs are still available for alternate uses, so U.S. doctors could still prescribe them for COVID-19 – a practice known as off-label prescribing.
“There has never been any high-quality evidence suggesting that hydroxychloroquine 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, and “that, I’m sure, had influence on the FDA,” Nissen said.
Trump aggressively pushed the drug beginning in the first weeks of the outbreak and stunned medical professionals when he revealed he took the drug preemptively against infection.
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.
The FDA granted emergency use of the drugs for coronavirus patients in late March at the same time the U.S. government accepted 30 million doses of hydroxychloroquine and chloroquine that had been donated by two foreign drug manufacturers. Millions of those doses were shipped to U.S. hospitals to treat patient who weren’t enrolled in clinical trials.
The agency said Monday it revoked the authorization in consultation with the Biomedical Advanced Research and Development Authority, or BARDA, which had requested the emergency use.
BARDA’s former director said in April that he was removed from his job because he resisted political pressure from Trump appointees to allow widespread use of the malaria drugs. Rick Bright said he worked with FDA senior staff to limit the drugs’ authorization to patients hospitalized with COVID-19 and under professional supervision.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.