The Food and Drug Administration has cautioned against the use of hydroxychloroquine for COVID-19 treatment outside of hospitals or clinical trials due to the risk of heart problems.
“Hydroxychloroquine [has] not been shown to be safe and effective for treating or preventing COVID-19,” the FDA warned.
Both can cause abnormal heart rhythms and a dangerously rapid heart rate, the agency said in a statement.
Hydroxychloroquine is FDA-approved to treat or prevent malaria as well as autoimmune conditions such as lupus and rheumatoid arthritis.
The news came on what the president called a positive day, with the stock market up more than 900 points and indications of an early breakthrough for a vaccine.
Moderna’s experimental COVID-19 vaccine, the first to be tested in the US, produced protective antibodies in a small group of healthy volunteers, according to very early data released by the biotech company on Monday.
President Trump on Monday announced that he has been taking the anti-malarial drug hydroxychloroquine to ward off the coronavirus.
“You’d be surprised at how many people are taking it, especially the frontline workers before you catch it. The frontline workers — many, many are taking it. I happen to be taking it. I happen to be taking it — hydroxychloroquine,” Trump said at the White House following a roundtable with reps from the restaurant industry.
“A lot of good things have come out on the hydroxy. I’m taking hydroxychloroquine. I’ve been taking it. I hope to not be able to take it soon. But I think people should be allowed to,” he said.
“A couple of weeks ago, I started taking it. I’ve heard a lot of good stories. And if it is not good, I will tell you, right. I’m not going to get hurt by it. It has been around for 40 years for malaria, for lupus, for other things.”
The president said that he asked the White House physician about the drug, which he is taking in pill form, and said he would like to take it and that the doctor agreed.
When asked about evidence it works, Trump replied, “Here we go. Are you ready? Here’s my evidence. I get a lot of positive calls about it. The only negative I heard — was at the VA? People that aren’t big Trump fans.”
The Veterans Health Administration study examined more than 300 COVID-19 patients and concluded the drug could be dangerous and even lethal.
The president talked about the letters and calls he’d received about the drug from doctors, referring to one unidentified physician from Westchester County he said was extolling the drug’s benefits.
“He said out of hundreds of people that he’s treated he hasn’t lost one. All I can tell you is, so far I seem to be OK. If it doesn’t work you’re not going to get sick or die. It’s been heavily tested,” Trump said.
“I’ve taken it about a week and a half now, and I’m still here. I get a lot of tremendously positive news on the hydroxy, and you know the expression I use, ‘What do you have to lose?’ ” he said, reporting he had “zero symptoms” or side effects despite warnings about taking the drug outside of a hospital setting.
The president would not say if other members of his family or administration were taking hydroxychloroquine, but said he had been also been taking zinc supplements.
He revealed the news after a reporter asked about former CDC official Rick Bright, who filed a whistleblower complaint alleging that he was transferred from his post working on a vaccine for resisting what he called political pressure to push the drug.
“I was just waiting to see your eyes light up when I said this,” the president said.
While some initial studies appeared to support the drug’s benefits, others showed mixed results or even that it could be dangerous for people with certain conditions.