U.S. revokes use of drugs touted by Trump vs. virus
— 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 Foodand Drug Administration said the drugs hydroxy- chloroquine 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 announce- ment, the FDA also warned doctors against prescribing the drugs in combination with remdesivir, the lone drug cur- rently shown to help patients with COVID-19. The FDA said the anti-malaria drugs can reduce the effectiveness of remdesivir, which FDAcleared 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 snap- shot of complications with the drugs because many side effects go unreported.
FDA’s move means that ship- ments 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,and “that, I’m sure, had influence on the FDA,” Nissen said.
The actions by FDA and NIH send a clear signal to health professionals against prescribing the drugs for coronavirus.
Trump aggressively pushed hydroxychloroquine beginning in the first weeks of the outbreak and stunned medical professionals when he revealed he had taken the drug preemptively against infection. After Trump’s repeated promotions, prescriptions for hydroxychloroquine soared, contributing to shortages.