FDA urges close monitoring of off-label chloroquine, hydroxychloroquine use to treat COVID-19 citing known heart rhythm risks

The FDA issued a safety communication Friday reiterating the need for close patient supervision when they are prescribed chloroquine or hydroxychloroquine, saying known side effects such as "serious and potentially life-threatening heart rhythm problems" have been reported when the antimalarial drugs have been used to treat or prevent COVID-19, an indication for which they are not approved. "We understand that healthcare professionals are looking for every possible treatment option for their patients," commented FDA Commissioner Stephen Hahn, but "while clinical trials are ongoing to determine the safety and effectiveness of these drugs for COVID-19, there are known side effects…that should be considered."

The known risks for chloroquine and hydroxychloroquine, which are already specified in the labels for their approved uses, are also indicated in the FDA emergency-use authorisation recently granted for the drugs to treat COVID-19. Both are currently FDA-approved to treat or prevent malaria, while hydroxychloroquine is also cleared in the US for autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults and rheumatoid arthritis.

In its safety communication, the FDA said it has reviewed case reports logged in its Adverse Event Reporting System database, published medical literature and the American Association of Poison Control Centers National Poison Data System showing "concerning serious heart-related adverse events and death" in patients with COVID-19 given hydroxychloroquine and chloroquine, either alone or combined with the antibiotic azithromycin or other medicines. Adverse events included abnormal heart rhythms such as QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases even death. The agency noted that patients with underlying health issues such as heart and kidney disease are likely to be at greater risk of these problems when receiving these medicines.

"We will continue to investigate risks associated with the use of hydroxychloroquine and chloroquine for COVID-19 and communicate publicly when we have more information," the FDA stated. The European Medicines Agency has also issued a warning reminding about potential heart rhythm problems associated with the two drugs.

A panel of medical experts convened by the US National Institutes of Health recently issued treatment guidelines for COVID-19 in which it highlighted that there was not enough evidence to recommend either for or against using hydroxychloroquine or chloroquine to treat SARS-CoV-2 infection. However, the panel did come out against using hydroxychloroquine plus azithromycin to treat COVID-19 patients due to the "potential for toxicities." US President Donald Trump had touted this particular combination as being a possible "game-changer" in dealing with the pandemic.

Meanwhile, the news also follows allegations from Rick Bright, the former director of the US Biomedical Advanced Research and Development Authority (BARDA), that he was demoted from his position recently because he resisted efforts to back broad use of chloroquine and hydroxychloroquine to treat COVID-19. Bright said he clashed with members of the US administration who have promoted the drugs "as a panacea, but which clearly lack scientific merit."

For related analysis, see KOL Views Results: French physician says hospital weathered first COVID-19 wave leaning on hydroxychloroquine but wary of next wave.

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