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August 30, 2021 – In 2021, in the United States alone, there have been more than 560,000 prescriptions of hydroxychloroquine for the prevention, post-exposure and treatment of COVID-19. Since the onset in February 2020, the U.S. has been the epicenter of the pandemic and remains the world leader in cases and deaths. Last year, the 890,000 prescriptions for hydroxychloroquine were nine-fold greater than the previous years, leading to major shortages for the approved indications of autoimmune disease predominantly in younger women.     

In a commentary published in The American Journal of Medicine, researchers from Florida Atlantic University’s Schmidt College of Medicine and collaborators review the recent major randomized, double-blind placebo-controlled trials and present an updated meta-analysis of hydroxychloroquine in post-exposure prophylaxis as well as in hospitalized patients. Last year, these same researchers issued a plea for a moratorium on prescription of hydroxychloroquine in prevention or treatment pending the outcome of ongoing randomized trials. 

“The updated randomized evidence provides even stronger support for the halt on prescribing hydroxychloroquine in the prevention or treatment of COVID-19,” said Charles H. Hennekens, M.D., Dr.PH, senior author, the first Sir Richard Doll professor and senior academic advisor in FAU’s Schmidt College of Medicine.

The authors say that in addition to a lack of significant benefit, the new randomized evidence shows some suggestion of harm. They explain that the prior reassuring safety profile of hydroxychloroquine is applicable to patients with lupus and rheumatoid arthritis, both of which are of greater prevalence in younger and middle-age women, whose risks of fatal heart outcomes due to hydroxychloroquine are reassuringly very low.

In contrast, the risks of hydroxychloroquine for patients with COVID-19 are significantly higher because fatal cardiovascular complications due to these drugs are so much higher in older patients and those with existing heart disease or its risk factors, both of whom are more predominant in men. 

“Premature and avoidable deaths will continue to occur if people take hydroxychloroquine and avoid the public health strategies of proven benefit, which include vaccinations and masking,” added Hennekens. 

Co-authors are Manas Rane, M.D., a preventive cardiology fellow at the Harvard Medical School and Boston VA System and a former FAU internal medicine resident; Joshua J. Solano, M.D., an assistant professor of emergency medicine; Scott M. Alter, M.D., M.B.A., an associate professor of emergency medicine; and Richard D. Shih, M.D., a professor of emergency medicine; all within the Schmidt College of Medicine; Dennis G. Maki, M.D., Ovid O. Meyer Professor of Medicine, and David L. DeMets, Ph.D., Max Halperin Professor of Biostatistics, emeritus, and former founding chair of the Department of Biostatistics and Medical Informatics, both with the University of Wisconsin School of Medicine and Public Health; Heather Johnson, M.D., preventive cardiologist at Lynn Women’s Health and Wellness Institute, Boca Raton Regional Hospital/Baptist Health South Florida and an adjunct professor at the University of Wisconsin School of Medicine and Public Health; and Shiv Krishnaswamy, a fourth-year medical student, FAU Schmidt College of Medicine.

Hennekens and Maki have been collaborators since 1969, when they served as lieutenant commanders in the U.S. Public Health Service as epidemic intelligence service officers with the U.S. Centers for Disease Control and Prevention. Hennekens, Maki and Johnson also collaborated on a recently published commentary emphasizing the already alarming racial inequalities in mortality from COVID-19, which are only likely to increase further until the vaccines are distributed equitably.