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Heart Warning From FDA Deals New Blow to Hyped Covid Therapy

FDA Issues Safety Warning on Drugs Trump Has Touted for Covid-19

(Bloomberg) -- The Food and Drug Administration warned of potential serious heart risks from malaria drugs touted by President Donald Trump for Covid-19, becoming the latest U.S. agency to dial back hopes of a quick pharmaceutical solution to the coronavirus pandemic.

Trump has grasped for off-the-shelf fixes to stem the pandemic’s risks to the U.S. and restart the economy, at times dabbling with unproven or dangerous ideas. At a press briefing Thursday, he appeared to suggest administering cleaning products or ultraviolet light inside the body to fight the virus. On Friday, he said his remarks were intended as a joke and that people should not ingest disinfectant.

The president has also been a proponent of giving coronavirus patients the antimalarial drugs chloroquine and hydroxychloroquine. Those medications emerged as possible treatments around the time a small and controversial French study showed early promise. Trump amplified the findings on Twitter, where his claims were widely recycled, and the drugs had been held up as a promising cure by personalities on Fox News.

But the FDA said on Friday Covid-19 patients shouldn’t take the drugs unless they’re carefully monitored in a hospital or as part of a clinical trial. The advisory follows similar warnings from other major U.S. medical groups.

The warning was the latest blow delivered by a government agency this week to the idea of using the drugs widely to treat the pandemic. A National Institutes of Health expert panel recommended against using hydroxychloroquine with the antibiotic azithromycin Tuesday. Meanwhile, a preliminary analysis from a New York-sponsored observational study found that hydroxychloroquine had no benefit in treating hospitalized patients with severe cases of Covid-19.

Additionally, a senior U.S. health official responsible for coordinating research efforts for drugs and vaccines for the coronavirus said he was being pushed out of his role because of concerns he had raised about the use of the malaria drugs.

There have been indications for some time that the drugs carry risks, particularly if used in very sick Covid-19 patients with existing heart conditions. The medicines have long been known to increase the risk of abnormal heart rhythm, particularly when taken in certain combinations or by those who have risk factors for sudden cardiac death.

Wary Cardiologists

Cardiologists immediately recognized the dangers of using both hydroxychloroquine and chloroquine broadly for Covid-19. About 1% of people worldwide may be at higher risk for developing the heart rhythm abnormality, an electrical disturbance where the heart muscle takes longer than normal to recharge between beats, said Michael Ackerman, a genetic cardiologist at the Mayo Clinic in Rochester, Minnesota.

Only a small fraction of those who get the drugs may experience life-threatening complications. But if they are given widely, even a small increase in risk could result in harm to many patients. Ackerman estimated that if 60,000 people were taking the drugs, 600 would be at risk for serious complications and as many as 60 would die.

“Some might say we just accept those 60 deaths as friendly fire,” he said. “Hopefully these drugs will work, but we need to be respectful of this unwanted side effect.”

While large trials have yet to show whether the medications could have a role in treating the new coronavirus, results from several small preliminary studies in recent weeks have suggested hydroxychloroquine or sister drug chloroquine may cause harm in sick Covid-19 patients, especially at higher doses.

On Friday, the Journal of the American Medical Association reported the results of a small, randomized trial of chloroquine in 81 hospitalized patients with severe Covid-19 in Brazil. An interim analysis found that high doses of the drug were associated with more lethal and toxic effects, particularly among those with heart complications. The patients were all also receiving azithromycin.

Troubling Reports

The FDA said Friday that it was issuing its warning after reports that patients taking the drugs, especially in combination with azithromycin, had experienced heart issues. The agency warned the drugs can cause abnormal heart rhythms as well as a dangerously rapid heart rate called ventricular tachycardia.

“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,” the health agency said in the warning. “Patients who also have other health issues such as heart and kidney disease are likely to be at increased risk of these heart problems when receiving these medicines.”

The agency has cleared some emergency uses of the medications, but it emphasized Friday that they haven’t been officially authorized for Covid-19 treatment or prevention. Doctors in the U.S. can prescribe whatever drugs they want, however, and many hospitals have been furiously adding large quantities of the medications to their stockpiles, out of fear that the relentless promotion of them on social media and elsewhere could make them hard to come by if proved effective against the virus.

Some studies have cast doubt on whether hydroxychloroquine has had any benefit in Covid-19 patients. A preliminary analysis from a New York State Department of Health-sponsored study found hydroxychloroquine had no statistically significant benefit or harm in severely ill Covid-19 patients.

David Holtgrave, dean of the University of Albany School of Public Health, examined the medical records of 600 patients treated with hydroxychloroquine at 22 of the state’s hardest-hit hospitals and health systems. The patients, who had either been discharged or had died, were given different dosages and treatment regimens.

“There wasn’t much effect one way or another,” Holtgrave said of the antimalarial drug. He intends to share more robust results from a sample of 1,500 patients with New York officials next week.

Controversial Therapy

Hydroxychloroquine has been one of the most-watched treatments being studied in Covid-19 patients. Chloroquine, a more toxic relative of hydroxychloroquine, has previously been tested in human trials against various viral diseases including influenza, dengue fever and chikungunya. It repeatedly failed to stop those diseases.

The FDA said it was aware of a surge in hydroxychloroquine and chloroquine prescriptions being filled outside hospitals. The drugs have fallen into short supply, jeopardizing access for patients who take them for lupus and rheumatoid arthritis, despite warnings from top medical groups of potential harm.

The American Heart Association, the American College of Cardiology and the Heart Rhythm Society issued guidance on April 8 stating that hydroxychloroquine and azithromycin “have potential serious implications for people with existing cardiovascular disease” and urged careful consideration of using them as Covid-19 treatments in combination, particularly given the two medications have not been studied together.

“The urgency of Covid-19 must not diminish the scientific rigor with which we approach Covid-19 treatment,” said Robert Harrington, president of the American Heart Association, in a statement.

Nearly 100 late-stage clinical trials have been launched globally to determine whether hydroxychloroquine could serve as a preventive therapy or as a treatment for patients who have contracted Covid-19, according to ClinicalTrials.gov.

©2020 Bloomberg L.P.