(AP) – United states regulators on Monday revoked emergency authorisation 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.”
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.
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.