US agency ‘cautions’ on anti-malarial, Trump backs off cure claims
The US Food and Drug Administration (FDA) issued a strong caution against the use of an anti-malarial drug to treat the novel coronavirus, saying it may pose heart risks, as a major new study showed the doses may lead to higher death rates.
“Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing Covid-19,” the FDA said.
The use of the drug should “be limited to clinical trial settings or for treating certain hospitalized patients” under the specialized emergency use authorization.
The FDA warning is the latest in a widespread pushback of dubious coronavirus treatments President Donald Trump has floated.
On Thursday Trump posed the question as to whether ultraviolet rays and disinfectants, which are poisonous, could be used to treat the coronavirus.
On Friday Trump walked back the statement, saying he asked the questions “sarcastically” to reporters, however, that assertion was not made clear at the time.
“I thought it was clear,” Trump added.
The anti-malarial drugs are the most prominent of treatments Trump has promoted without concrete scientific backing.
Trump has repeatedly touted the potential value of the anti-malarials, including from the White House podium during press conferences. Anecdotal evidence indicates his public insistence led patients to seek out the drug from their doctors.
He generally phrases his push of the drug by saying “what have you got to lose?” while also sometimes adding a caveat that it should be done under medical supervision.
Recent research has pointed to potential organ problems for people who use the drugs, notably heart issues.
The latest major study, done in Brazil and published on Friday in the Journal of the American Medical Association (JAMA), warned of a potential greater death rate among patients given chloroquine and said the research had to be cut short.
The study “was not sufficiently safe to warrant continuation of that study group,” the JAMA article said.
The article said there was no apparent benefit to the drug and questioned its continued use outside of clinical trials.
Rick Bright, a vaccine scientist working for a key federal government agency, recently said he was ousted from his role for rejecting the use of the anti-malarial drug, adding to the political tensions around a treatment so deeply associated with the president.
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“FDA cautions against use of hydroxychloroquine or chloroquine for Covid-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems,” the federal regulator said in its updated caution.
New York Governor Andrew Cuomo on Thursday said studies in his state, the epicentre of the US outbreak, showed that the anti-malarials had little positive effect on recovery rates, while adding that little negative data had emerged. (dpa)
