FDA Warns Against Wide Use Of The Drugs Trump Hailed As 'Game Changers'

Enlarge this image toggle caption Mandel Ngan/AFP via Getty Images Mandel Ngan/AFP via Getty Images

President Trump has spiritedly backed hydroxychloroquine and azithromycin, both in his regular news briefings and on his Twitter account. He has said the two drugs, when taken together to treat the coronavirus, could become "one of the biggest game changers in the history of medicine."

That may well be, eventually — but not right now.

The Food and Drug Administration strongly warned Friday against using hydroxychloroquine or a related compound, chloroquine, for treating or preventing COVID-19 without strict medical supervision in a hospital or as part of a clinical trial. The agency said its officials have not approved the anti-malaria drugs for that purpose — and that without close monitoring for side effects, they may lead to life-threatening complications.

"We understand that health care professionals are looking for every possible treatment option for their patients and we want to ensure we're providing them with the appropriate information needed for them to make the best medical decisions," FDA Commissioner Stephen M. Hahn said.

"While clinical trials are ongoing to determine the safety and effectiveness of these drugs for COVID-19, there are known side effects of these medications that should be considered," he added. "We encourage health care professionals making individual patient decisions closely screen and monitor those patients to help mitigate these risks."

The FDA said it has received reports in its adverse event reporting system and from poison control centers, detailing "serious heart-related adverse events and death in patients with COVID-19 receiving hydroxychloroquine and chloroquine." These include a rapid heartbeat known as ventricular tachycardia, among other forms of heart rhythm disturbances. The reported side effects occurred when the medications were used alone and combined with the antibiotic azithromycin.

The FDA's announcement comes just several days after a panel convened by the National Institute of Allergy and Infectious Diseases issued a similar warning, specifically about using a combination of hydroxychloroquine and azithromycin.

In its warning earlier this week, the panel laid out guidelines on certain therapies and potential treatments for COVID-19. Ultimately, the guidelines found that there was insufficient evidence to recommend any treatment, in particular, while they await the results of formal clinical trials.

Trump, however, has not shared the caution of the scientists supporting his coronavirus task force. The president repeatedly urged that the drugs receive serious consideration from researchers and patients — and quickly.

"What do you have to lose? They say, 'Take it.' I'm not looking at it one way or the other, but we want to get out of this," he told a news conference earlier this month. "If it does work, it would be a shame if we didn't do it early."

At least one person lost his life ingesting a form of chloroquine, not long after the president expressed hope on Twitter that the FDA will allow the drugs to "be put into use IMMEDIATELY."

The agency said in its warning Friday that its earlier authorization to use these drugs for COVID-19 was limited to hospital patients when clinical trials are not available or where a patient can't participate in a study.

The FDA says patients already taking the drugs for their more widely approved uses should continue hydroxychloroquine and chloroquine as prescribed and should consult a health care professional if side effects occur. Chloroquine and hydroxychloroquine are approved to treat malaria. Hydroxychloroquine is also approved to treat immune system conditions such as lupus and rheumatoid arthritis.

On Friday, after controversy stirred around another of Trump's midbriefing conjectures, the White House press secretary defended the president's news briefings, saying that he has "repeatedly said that Americans should consult with medical doctors regarding coronavirus treatment."