A new study warns that taking hydroxychloroquine with or without Zithromax to treat COVID-19 may cause people to experience heart rhythm problems that could potentially lead to major complications, including heart attack, stroke, seizure and death. The study was published in the journal JAMA Cardiology on May 1, in the midst of the coronavirus outbreak, a global health crisis that has induced panic and prompted many people to try COVID-19 treatments that have not been proven effective, which could put them at risk for serious side effects. According to the researchers in this new study, patients who tested positive for COVID-19 and took hydroxychloroquine, either alone or in combination with the antibiotic azithromycin (Zithromax or Z-Pak), faced a greater risk of potentially dangerous corrected QT (QTc) prolongation and cardiac arrhythmias.
There have been several studies conducted in recent months that have sought to examine the potential effectiveness of hydroxychloroquine in treating COVID-19. This is due in large part to the fact that President Donald Trump has suggested on numerous occasions that the medication could be an effective treatment, despite a lack of evidence suggesting that the drug can actually help hospitalized patients with COVID-19 recover from the illness. In this latest study, researchers from the Beth Israel Deaconess Medical Center and Harvard Medical School in Boston, Massachusetts assessed the outcomes of 90 hospitalized patients with coronavirus-associated pneumonia who received at least one day of hydroxychloroquine treatment between March 1, 2020 and April 7, 2020.
Hydroxychloroquine is a medication intended for the prevention or treatment of malaria caused by mosquito bites and the drug is also sometimes used to treat autoimmune conditions like lupus and rheumatoid arthritis. Azithromycin, best known by the brand names Zithromax and Z-Pak, is used to treat a variety of bacterial infections, including respiratory infections. During the ongoing coronavirus public health crisis, hydroxychloroquine has been used alone and in combination with azithromycin to treat hospitalized patients with COVID-19. As of May 7, more than one million confirmed cases of COVID-19 have been reported in the United States, with nearly 75,000 deaths. Yet there are still no FDA-approved treatments for coronavirus, nor is there a vaccine.
“The presumed efficacy and widespread use of hydroxychloroquine stemmed from in vitro evaluations of severe acute respiratory syndrome coronavirus 1 (SARS-CoV-1) and SARS-CoV-2 and a small prospective study claiming virologic clearance in six patients taking hydroxychloroquine with azithromycin,” the researchers note in this new JAMA Cardiology study. “The combination gained further attention after coverage by the lay press; however, subsequent studies have failed to replicate these findings.” While hydroxychloroquine and azithromycin are generally well-tolerated drugs used in clinical practice, both can cause corrected QT (QTc) prolongation, which carries a risk of sudden cardiac death.
On April 24, the FDA issued a Drug Safety Communication cautioning against the use of hydroxychloroquine or chloroquine for coronavirus outside of a hospital setting or clinical trial, due to a risk of heart rhythm problems. “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 FDA statement read. The agency also reminded consumers and healthcare professionals that “Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19.”
Among the 90 coronavirus patients treated with hydroxychloroquine in the JAMA Cardiology study, 53 received concomitant azithromycin. The researchers found that the administration of hydroxychloroquine with or without azithromycin for the treatment of COVID-19-associated pneumonia carried an elevated risk of QT prolongation and cardiac arrhythmias. They also found that patients treated with hydroxychloroquine and azithromycin experienced greater changes in QTc, compared to those treated with hydroxychloroquine only. Based on their findings, the researchers recommended that clinicians “carefully weigh risks and benefits if considering hydroxychloroquine and azithromycin, with close monitoring of QTc and concomitant medication usage.”
There is substantial evidence suggesting that hydroxychloroquine can cause heart rhythm problems like QT interval prolongation or ventricular tachycardia, a condition characterized by a dangerously rapid heart rate. In this latest study, nearly 90% of patients taking hydroxychloroquine by itself or in combination with Zithromax experienced QT prolongation. And patients taking both medications experienced more pronounced changes to their heart rhythm. The researchers warn that the potential increased risk of heart rhythm problems in COVID-19-positive patients taking hydroxychloroquine with or without azithromycin is further complicated by the fact that patients with underlying cardiac conditions may be disproportionately affected by COVID-19 and that the virus itself may “provoke myocardial injury.”