Hydroxychloroquine for Coronavirus: The Urgent Need for a Moratorium on Prescriptions

Many issues concerning the prescription of chloroquine and hydroxychloroquine in the treatment and prevention of coronavirus 2019 (COVID-19) have been addressed in recent peer-reviewed publications in high-quality journals. Nonetheless, the widespread prescriptions by health care providers are 9 times greater than in the last several years.

Perhaps this is due, in part, to the compassion of health care providers to do more good than harm in an ever increasingly alarming pandemic. Specifically, as of May 14, 2020, in the United States there have been over 1.3 million reported cases and over 84,000 deaths from COVID-19. Worldwide, the corresponding figures are over 4.3 million cases and almost 300,000 deaths. Thus, the United States accounts for over 30% of the cases and over 25% of the deaths while comprising only about 4.5% of the world’s population. Of further alarm to health care providers and patients is that, at present, even without widespread rapid testing, the United States has already reported about 4 times the number of cases of any other country in the world, and even after adjusting for the population sizes, over 46 times the number of deaths of South Korea, whose first case was reported on the same day as that of the United States.

It is also likely that widespread lay media reports, as well as statements by the highest-ranking US government officials, have also been a contributing factor. On April 4, 2020, the President of the United States publicly stated: “What do you have to lose? Take it, I really think they should take it.” During the next 24 hours, the prescriptions of these drugs by health care providers skyrocketed to 46-fold above usual patterns.

The continued widespread prescriptions by health care providers of these drugs for COVID-19 are, in turn, leading to nationwide shortages. Thus, patients with systemic lupus erythematosus and rheumatoid arthritis, for whom hydroxychloroquine has been an approved indication for decades, are unable to refill their prescriptions.

In this Commentary, we review the totality of available evidence and conclude that there is an urgent need for a moratorium on the prescription of these drugs in the treatment and prevention of COVID-19.

When the totality of evidence is incomplete, it is appropriate for health care providers to remain uncertain. Nonetheless, regulatory authorities are sometimes compelled to act on incomplete evidence. On March 28, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization for chloroquine and hydroxychloroquine for the treatment of COVID-19. By April 24, 2020, the FDA issued a Drug Safety Communication warning about potentially fatal prolongations of the QTc interval detectable on 12-lead electrocardiograms and risks of other serious cardiac arrhythmias. Thus, with chloroquine and hydroxychloroquine, as sometimes is the case, the accumulation of further reliable data later did not support the early regulatory action.

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