https://www.miamiherald.com/news/coronavirus/article242262731.html
FDA issues hydroxychloroquine warning as studies show risk in using drug for COVID-19
The anti-malarial drugs hydroxychloroquine and chloroquine were an early contendermuch toutedby President Donald Trump for treating the coronavirus.
But findings in recent studies highlighting the drug’s potentially fatal side effects forced the U.S. Food and Drug Administration’s hand on Friday.
“Hydroxychloroquine and chloroquine have not been shownto be safe and effectivefor treating or preventing COVID-19,” the FDA said in a notice cautioning against their use outside of hospitals and clinical trials.
“Close supervision is strongly recommended,” the warning states.
CLINICAL TRIAL RESULTS
There are currently no FDA-approved drugs to treat COVID-19, but hydroxychloroquine and chloroquine have been approved for clinical trials in the U.S. and wereissued emergency authorizationfor use in coronavirus patients without access to a trial.
According to the U.S. National Library of Medicine, itsside effectsrange from mild — such as dizziness, nausea and diarrhea — to severe — including sensitivity to light, bleeding, muscle weakness, hair loss and convulsions.
In extreme cases, the drugs can cause “sudden cardiac death,” NBC News reported.
Hydroxychloroquine treatments inFranceandSwedenwere cut short earlier this month “after reports of severe side effects,” according to Newsweek.
As of April 14, there wereat least 142 trialsinvolving chloroquine and hydroxychloroquine, according to the Oxford Centre for Evidence-Based Medicine.
Five have issued reports on their findings — the first two of which have been used to back the use of chloroquine and hydroxychloroquine in COVID-19 patients, CEBM said. The latter three “are all negative.”
Researchers with another study in Brazilreleased their findingsFriday in the peer-reviewed Journal of the American Medical Association, CNBC reported. They had to cut the study short after nearly two dozen patients died from daily dosages of chloroquine.
“We recommend that similar dosagesno longer be usedfor the treatment of severe COVID-19, especially because treatment based on older patients with previous cardiac diseases who are receiving concomitant cardiotoxic drugs should be the rule,” researchers said in the report.
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