FDA Warns of Heart Rhythm Issues with Promising COVID-19 Drugs

The FDA recently issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, which have been deemed as two of the most promising COVID-19 drugs. 

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The side effects of the anti-malaria drugs include serious and potentially life-threatening heart rhythm problems and could lead to worse outcomes for COVID-19 patients. 

“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,” said FDA Commissioner Stephen M. Hahn, MD. 

“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. We encourage health care professionals making individual patient decisions to closely screen and monitor those patients to help mitigate these risks. The FDA will continue to monitor and investigate these potential risks and will communicate publicly when more information is available.”

The FDA recently issued an emergency use authorization (EUA) to allow hydroxychloroquine and chloroquine products donated to the Strategic National Stockpile (SNS) to be distributed and used in specific circumstances, such as for certain hospitalized patients with COVID-19 when clinical trials are not available or feasible.

As part of the EUA, HHS accepted 30 million doses of hydroxychloroquine sulfate, donated by Sandoz, and chloroquine, donated by Bayer Pharmaceuticals, to distribute to hospitals across the country. They intended to slow the progression of COVID-19 in seriously ill patients and relieve the acute respiratory symptoms in infected patients.

Although the drugs are not approved by FDA, limited clinical data has shown that chloroquine phosphate and hydroxychloroquine sulfate may be viable COVID-19 treatments.

Clinical trials are currently underway and additional trials are being planned to determine if these drugs are effective. 

One recent study will uncover if hydroxychloroquine can prevent coronavirus among healthcare workers, first responders, or individuals who have been in close contact with someone with COVID-19.

The study, being led by Henry Ford Health System, started enrollment April 9 and will be the first major, definitive study in healthcare workers and first responders of hydroxychloroquine as a coronavirus preventative. 

William W. O’Neill, MD, the Henry Ford Health System’s study’s organizer, a cardiologist and researcher, stressed that the study will uncover the most vital question on everyone’s mind, “Does hydroxychloroquine work?” 

The recent FDA announcement said that once the agency has approved the drug, healthcare providers may be able to prescribe hydroxychloroquine for unapproved use. The decision will be based on an assessment of benefits versus risks for the patient. 

Last week, a retrospective analysis of data found no evidence that the use of hydroxychloroquine, with or without azithromycin, reduced the risk of ventilation in patients hospitalized with COVID-19.

The study from the Department of Veteran Affairs analyzed the outcomes of 368 patients with SARS-CoV-2 in all US Veterans Health Administration medical centers. Researchers focused on hospitalization (discharge or death), whether ventilation was required, and the result of hospitalization among patients requiring ventilation. 

Researchers found no notable difference in the risk of ventilation in either the hydroxychloroquine group or the hydroxychloroquine and azithromycin group, compared to the group not exposed to hydroxychloroquine. 

There was a higher risk of death from any cause in the hydroxychloroquine group but not in the hydroxychloroquine and azithromycin group. Death rates in the hydroxychloroquine group, hydroxychloroquine and azithromycin, and no hydroxychloroquine were 27.8 percent, 22.1 percent, and 11.4 percent, respectively. 

The rate of ventilation in the hydroxychloroquine group, hydroxychloroquine and azithromycin group, and no hydroxychloroquine group were 13.3 percent, 6.9 percent, and 14.1 percent, respectively. 

“Data from ongoing, randomized controlled studies will prove informative when they emerge. Until then, the findings from this retrospective study suggest caution in using hydroxychloroquine in hospitalized COVID-19 patients, particularly when not combined with azithromycin,” researchers concluded.