The drugs, hydroxychloroquine and chloroquine, have been repeatedly promoted by President Trump. But they should be used only in clinical trials or hospitals, the agency said.
The Food and Drug Administration issued a safety warning on Friday about hydroxychloroquine and chloroquine, malaria drugs that have been promoted by President Trump repeatedly and widely used to treat coronavirus patients despite the lack of evidence that they work.
The drugs can cause dangerous abnormalities in heart rhythm in coronavirus patients, and should be used only in clinical trials or hospitals where patients can be closely monitored for heart problems, the Food and Drug Administration warned in a safety communication issued on Friday.
Top health experts have regularly contradicted the president.. This week, a federal official abruptly removed from his post as head of an agency involved in development of a vaccine, complained that he was pressured to endorse these drugs without adequate science. Administration officials said he had been dismissed for other reasons.
With no vaccine or effective treatment for Covid-19, the disease caused by the coronavirus, many hospitals have been using hydroxychloroquine, sometimes with the antibiotic azithromycin, in the hope that they might help. In recent interviews, doctors around the country have cited their desperate need to help patients and try potential treatments despite limited evidence.
Results of small studies have trickled out in the last few weeks that signaled more problems with using the malaria drugs to treat coronavirus patients. The latest report, on Friday in the journal Nature Medicine, describes abnormal heart rhythms in 84 patients treated with the drugs.
Several medical societies, including the Infectious Diseases Society of America, the American Thoracic Society and the American College of Cardiology, have warned of the risks of using malaria drugs with azithromycin to treat patients with Covid-19 outside of a clinical trial or without close monitoring.
“The F. D. A. is aware of reports of serious heart rhythm problems in patients with Covid-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin” and other drugs that can disrupt heart rhythm, the statement said.
