Researchers urge halt in prescribing hydroxycholoroquine for COVID-19


Date:
June 3, 2020
Source:
Florida Atlantic University
Summary:
Researchers urge a moratorium on prescribing chloroquine or
hydroxychloroquine, with or without azithromycin, to treat or
prevent COVID-19, and caution that the reassuring safety profile
of hydroxychloroquine may be more apparent than real. Safety data
derive from decades of prescriptions by clinicians, primarily for
their patients with lupus and rheumatoid arthritis, both of which
are of greater prevalence in younger and middle age women, who are
at very low risk of fatal heart outcomes due to hydroxychloroquine.



FULL STORY ==========================================================================
The sacred oath taken by physicians during graduation from medical school
to "First do no harm," the first words of the Hippocratic Oath, provides
a strong impetus for a commentary just published in The American Journal
of Medicine.

Researchers from Florida Atlantic University's Schmidt College of Medicine
and collaborators from the University of Wisconsin School of Medicine and Public Health are urging all health care providers to always prioritize compassion with reliable evidence on efficacy and safety. They recommend
a moratorium on the prescription of chloroquine or hydroxychloroquine,
with or without azithromycin, to treat or prevent COVID-19, with the
exceptions of obtaining the necessary evidence in randomized trials as
well as compassionate use.


========================================================================== Despite the fact, or perhaps due in part to the fact that there are no therapeutic or preventive measures for the COVID-19 pandemic in the
United States, which accounts for less than 5 percent of the world's
population and about 30 percent of the cases and deaths, the widespread prescriptions of these drugs are nine times greater than in the last
several years. This widespread use is leading to nationwide shortages in patients with lupus and rheumatoid arthritis, for whom hydroxychloroquine
has been an approved indication for decades. These patients are unable
to refill their prescriptions.

On March 28, the U.S. Food and Drug Administration (FDA) issued an
emergency use authorization for chloroquine and hydroxychloroquine for
the treatment of COVID-19. By April 24, however, the FDA issued a drug
safety communication warning regarding hydroxychloroquine and heart
rhythm disturbances that can lead to sudden cardiac death.

"If these drugs need to be prescribed for patients with COVID-19,
baseline evaluations and serial monitoring are an absolute necessity,"
said Richard D.

Shih, M.D., first author, a professor of emergency medicine and division director and founding program director for the emergency medicine
residency program in FAU's Schmidt College of Medicine.

Further, the authors point out that the reassuring safety profile of hydroxychloroquine may be more apparent than real. The data on safety
derive from decades of prescriptions by health care providers, primarily
for their 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 predominantly men.

In basic research, hydroxychloroquine and chloroquine are structurally
related and have similar mechanisms to inhibit the virus that
causes COVID-19. Despite their structural similarities, in vitro, hydroxychloroquine appears to be more effective. In addition, when used
for lupus and rheumatoid arthritis, hydroxychloroquine has fewer side
effects, less drug interactions and is less toxic in overdose. The
authors note that the currently available evidence is restricted to
eight published studies, five on hydroxychloroquine alone; two on hydroxychloroquine plus azithromycin; and one on both in combination
or alone.

Of these only three are randomized trials that enrolled 225, 62, and
30 patients -- all too small to provide reliable evidence. All three
tested hydroxychloroquine alone versus standard of care in China. One
showed no significant difference in viral clearance at 28 days, the
second, no difference in viral clearance at seven days, and the third,
some improvements in fever, cough and chest computed tomography findings.

"With respect to hypothesis testing, only large-scale randomized trials of sufficient size, dose and duration can reliably detect the most plausible small-to-moderate effects, which can have enormous clinical and public
health impacts," 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.

Co-authors include Heather M. Johnson, M.D., FACC, a preventive
cardiologist/ cardiologist at the Lynn Women's Health and Wellness
Institute at Boca Raton Regional Hospital/Baptist Health South Florida,
and Dennis G. Maki, M.D., professor emeritus in the Department of Medicine
at the University of Wisconsin School of Medicine and Public Health,
where Johnson also is an adjunct associate professor.

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 in The American Journal of Medicine
concerning the already alarming racial inequalities in mortality from
COVID-19, which are only likely to increase further unless effective
drug therapies or vaccines are distributed equitably.


========================================================================== Story Source: Materials provided by Florida_Atlantic_University. Original written by Gisele Galoustian. Note: Content may be edited for style
and length.


========================================================================== Journal Reference:
1. Richard D. Shih, Heather M. Johnson, Dennis G. Maki, Charles H.

Hennekens. Hydroxychloroquine for Coronavirus: The Urgent Need for
a Moratorium on Prescriptions. The American Journal of Medicine,
2020; DOI: 10.1016/j.amjmed.2020.05.005 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2020/06/200603130014.htm https://www.sciencedaily.com/releases/2020/06/200603130014.htm

--- up 19 weeks, 1 day, 3 hours, 31 minutes
* Origin: -=> Castle Rock BBS <=- Now Husky HPT Powered! (1337:3/111)