April 24, 2020: “The U.S. Food and Drug Administration on Friday warned doctors against prescribing a malaria drug touted by President Donald Trump for treating the new coronavirus except in hospitals and research studies.
In an alert, regulators flagged reports of sometimes fatal heart side effects among coronavirus patients taking hydroxychloroquine or the related drug chloroquine.
The decades-old drugs, also prescribed for lupus and rheumatoid arthritis, can cause a number of side effects, including heart rhythm problems, severely low blood pressure and muscle or nerve damage.
The warning comes as doctors at a New York hospital published a report that heart rhythm abnormalities developed in most of 84 coronavirus patients treated with hydroxychloroquine and the antibiotic azithromycin, a combo Trump has promoted.
Both drugs are known to sometimes alter the heartbeat in dangerous ways, and their safety or ability to help people with COVID-19 is unknown.
A National Institutes of Health experts panel earlier this week recommended against taking that drug combo except in a formal study because of the side effects potential.
Last month, the FDA authorized limited use of malaria drugs for hospitalized patients with COVID-19 who aren’t enrolled in ongoing research.
The FDA said the drugs’ risks are manageable when patients are carefully screened and monitored by doctors. A number of studies are testing hydroxychloroquine as a treatment or for prevention of COVID-19.
Regulators said they are now investigating dangerous side effects and deaths reported with the malaria drugs to poison control centers and other health authorities.
“It is important that health care providers are aware of the risks of serious and potentially life-threatening heart rhythm problems that can occur with these drugs,” the FDA said in a statement. The agency did not specify the number of reports it has received of side effects or deaths.
Calls to U.S. poison control centers about the malaria drugs increased last month to 79, compared to 52 in March 2019, according to Dr Christopher Hoyte of the Rocky Mountain Poison Center in Denver, Colorado. The problems reported include abnormal heart rhythms, seizures, nausea and vomiting, Hoyte said.
Trump has repeatedly touted hydroxychloroquine during his regular coronavirus briefings, suggesting its skeptics would be proven wrong. He has offered patient testimonials that the drug is a lifesaver.
But a number of early coronavirus studies have suggested problems or no benefit.
https://www.usnews.com/news/health-news/articles/2020-04-24/fda-warns-of-risks-with-trump-promoted-malaria-drug
