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Researchers urge halt in prescribing HCQ for Covid-19 in US
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IANS | 04 Jun, 2020
Researchers in the US have urged a temporary prohibition on prescribing
chloroquine or hydroxychloroquine (HCQ), with or without azithromycin,
to treat or prevent Covid-19.
Despite the fact that there are no
therapeutic or preventive measures for the Covid-19 pandemic in the US,
prescriptions of these drugs are nine times greater than in the last
several years.
According to the study, published in The American
Journal of Medicine, this widespread use is leading to nationwide
shortages in patients with lupus and rheumatoid arthritis, for whom HCQ
has been an approved indication for decades.
These patients are unable to refill their prescriptions.
"If
these drugs need to be prescribed for patients with Covid-19, baseline
evaluations and serial monitoring are an absolute necessity," said study
author Richard D. Shih from the Florida Atlantic University.
On
March 28, the US Food and Drug Administration (FDA) issued an emergency
use authorisation 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. The study
authors point out that the reassuring safety profile of HCQ may be more
apparent than real.
The data on safety derives 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 HCQ are reassuringly very low.
In contrast, the
risks of HCQ 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, HCQ and chloroquine are structurally related and have similar
mechanisms to inhibit the virus that causes Covid-19. The authors noted
that the currently available evidence is restricted to eight published
studies, five on HCQ alone; two on HCQ plus azithromycin; and one on
both in combination or alone.
Of these only three are randomised
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 randomised 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 study senior Charles H Hennekens.
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