WASHINGTON (CN) — Drugs touted by President Donald Trump for coronavirus treatment have caused serious heart problems in coronavirus patients who have taken them, the U.S. Food and Drug Administration warned Friday.
“The FDA 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 QT prolonging medicines,” the administration announced.
In an electrocardiogram, measurements between Q and T waves reflect how long it takes the heart muscle to recharge between beats.
Though less so lately, as troubling studies about the drug have begun to mount, Trump has for months been pushing the combination of chloroquine or hydroxychloroquine and the antibiotic azithromycin as a “game changer” in the war on Covid-19.
Across the United States, state and local governments have obtained a stockpile of around 30 million doses of the antimalarial drug. Because of the risk of heart-rhythm problems, the FDA says it recommends the drug only by taken under close supervision, strictly in a hospital setting or in a clinical trial.
“We are also aware of increased use of these medicines through outpatient prescriptions,” Friday’s release by the FDA continues. “Therefore, we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine.”
This is possible because once a drug has been approved by the FDA for one use, doctors can prescribe it for any treatment — they are not restricted to prescribing it solely for the conditions it has been promoted and approved for use.
Robert Field, a professor of law and health management and policy at Drexel University, said in an interview Friday afternoon that the FDA’s statement was not surprising given the information that’s been coming out about the drugs.
“There’s minimal anecdotal data that it helps, but it’s been quite minimal,” Field said. “There’s been a fair amount of reporting on its toxicity, so it’s not surprising then objective review of the data would come to this conclusion.”
Earlier this week, a study in which researchers analyzed the medical records of 368 male veterans hospitalized with coronavirus showed disappointing results. Like many studies responding to the pandemic, the study has yet to be peer reviewed. It found that about 28% who received hydroxychloroquine and usual care died, versus 11% of those getting routine care alone. Calls to U.S. poison control centers involving the malaria drugs have also increased — from 52 calls in March 2019 to 79 in March 2020 — with issues being reported such as irregular heart rhythms, seizures, nausea and vomiting.
FDA Commissioner Stephen Hahn tweeted a reminder Friday that the drugs are not FDA approved for Covid-19 treatment. “These medicines have not been proven safe or effective for treating #COVID19,” he said, “but clinical trials are underway.”
To gather its data, the FDA reviewed case reports in the FDA Adverse Event Reporting System database, published medical literature, and the American Association of Poison Control Centers National Poison Data System.
“These adverse events were reported from the hospital and outpatient settings for treating or preventing Covid-19, and included QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases death,” the FDA release states.
Doctors in a New York hospital reported in one of the FDA-reviewed cases that heart rhythm abnormalities developed in most of the 84 coronavirus patients treated with hydroxychloroquine and azithromycin.
While Trump’s promotion of the drug treatment is controversial, it will likely not face legal consequences.
“If it were the manufacturer then there definitely would be; there are strict laws about promoting unapproved medication or promoting medications for unapproved uses,” Field explained. “Probably there is no direct liability and for a public official, probably not at all. Now, if it turned out that Trump had a financial interest in promoting use of the drug, it would be grounds for an investigation. But at this point, I don’t think they’re about to start another impeachment proceeding, so he probably is free of legal responsibility unless he knew that the drugs would be dangerous. Then he could be found liable for deliberately endangering people’s health and lives, but that would be hard to prove. Afterall, yesterday he announced that people should consider injecting themselves with disinfectants, so he’s really putting himself out there on the line in terms of legal exposure.”
Though he has since spun the remark as a joke — after the White House first claimed his nationally broadcast remarks were taken out of context — Trump spoke Thursday evening about injecting disinfectants to treat coronavirus infections.
The idea drew swift condemnation from health experts and politicians on Capitol Hill.
“Trump thinks ingesting chemical disinfectants might help kill the #COVID19 virus,” Representative Gerry Connolly, a Virginia Democrat, tweeted Friday. “His degenerating resort to quackery (see sunlight, and malaria medicines) is dangerously unbalanced, and Republican defense of the very stable genius is increasingly untenable.” (Parentheses in original.)
Field said politicians should not attempt to dispense medical advice during the pandemic.
“They should leave that to trained physicians,” he said. “And I think what the FDA just said today, bears that out. If I want to know how to deal with a health issue, I’d go see someone who’s trained and licensed to deal with health issues. I wouldn’t trust my health to a politician or to a real estate developer or to a reality show host.”