The FDA and medical experts are warning about heart rhythm issues and mortality when using hydroxychloroquine, particularly in combination with azithromycin (Zithromax), to treat COVID-19.
“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. We are also aware of increased use of these medicines through outpatient prescriptions,” the agency said in a press release. “Therefore, we would like to remind health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine.”
The abnormal heart rhythm risks include QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia.
Trending: Debate erupts over COVID-19 treatment
Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19, the agency said. “They are being studied in clinical trials for COVID-19, and we authorized their temporary use during the COVID-19 pandemic for treatment of the virus in hospitalized patients when clinical trials are not available, or participation is not feasible, through an Emergency Use Authorization (EUA).”
The drugs have been controversial since late March, when FDA issued an Emergency Use Authorization for their use in seriously ill, hospitalized COVID-19 patients.
President Donald Trump and his trade adviser, Peter Navarro, have promoted the drug to treat COVID-19 since the beginning of the U.S. outbreak. In fact, Trump said at a recent White House press briefing that he would ask his doctor about taking hydroxychloroquine to prevent getting COVID-19.
However, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases at the NIH, said that current studies only show anecdotal information that hydroxychloroquine works to combat COVID-19.
Fauci said more testing is needed before it’s clear that the drug works against the coronavirus and is safe for COVID-19 patients, Associated Press reported.
Stacking the deck against widespread chloroquine use to treat COVID-19 is a new study published in JAMA Network Open, which demonstrated heart risks and mortality when the medication was given at high doses.
Doctors in Brazil performed a parallel, double-blind, randomized clinical trial in a Brazilian population designed to assess the safety of chloroquine in dosages that, based on earlier research, were thought to be sufficient to exert antiviral effects, a correspond JAMA Network Open editorial said.
They compared a high dose of chloroquine, 600 mg. twice daily for 10 days with a lower-dose regimen, initially 450 mg. twice daily on the first day, tapering to 450 mg. once daily for 4 days
Patients enrolled in the trial exhibited fever and respiratory symptoms, along with tachypnea, tachycardia, hypoxemia, or hypotension. The primary outcome was death, originally planned to be assessed at 28 days after entry to the trial. Secondary outcomes included death at 13 days, electrocardiographic anomalies, recovery of viral RNA, and a number of clinical events, such as duration of mechanical ventilation and clinical status, the editorial said.
“The preliminary findings of this study suggest that the higher CQ dosage should not be recommended for critically ill patients with COVID-19 because of its potential safety hazards, especially when taken concurrently with azithromycin and oseltamivir (Tamiflu),” the researchers said in the original article.
However, the findings cannot be extrapolated to patients with mild COVID-19.
An infectious disease expert who took hydroxychloroquine plus azithromycin to treat his own case of COVID-19 is also wary about physicians widely prescribing the medications to treat the virus.
Michael Saag, MD, director of the Division of Infectious Disease at the University of Alabama, contracted COVID-19 in mid-March when traveling from New York to Alabama.
While he was not hospitalized, his symptoms were severe enough that, after consulting with several colleagues, he took a regimen of hydroxychloroquine plus azithromycin.
Saag based his decision on anecdotal reports of 20 patients who received hydroxychloroquine and hydroxychloroquine plus azithromycin in France. “I took the medication for 5 days, and I couldn’t tell whether it worked, which is why we need clinical trials to prove its efficacy and safety,” Saag told Physicians Practice.
To that end, the National Institutes of Health funded a new clinical trial of hydroxychlrooquen plus azithromycin at the University of Alabama for COVID-19 patients who have symptoms but do not requiring hospitalization — “someone like me,” Saag said.
Several other trials, including a large multicenter trial in the US, are also ongoing, the JAMA editorial said, "and hopefully will provide additional crucial information about the efficacy and safety of hydroxychloroquine.”
“For the time being, prudent clinicians should discuss with patients and their families, when feasible, the potential risks of this drug and the uncertain benefits before initiating it,” the editorial authors wrote.