COVID-19 treatment: FDA says hydroxychloroquine touted by Trump is not safe or effective
The Food and Drug Administration is warning against the use of two
drugs President Donald Trump has repeatedly touted as a possible "game
changer" in the fight against the coronavirus.
The Drug Safety Communication published Friday said the agency
cautions against the use of hydroxychloroquine or chloroquine for
COVID-19 treatment outside of hospitals or clinical trials due to the
risk of heart rhythm problems.
"Hydroxychloroquine and chloroquine have not been shown to be safe and
effective for treating or preventing COVID-19," the FDA warned. Both
can cause abnormal heart rhythms and a dangerously rapid heart rate,
the statement said.
The FDA explicitly warned consumers not buy the drugs from online
pharmacies without a prescription from a health care professional.
"Consumers should not take any form of chloroquine that has not been
prescribed for them by a healthcare professional," the agency stated
on its website.
A clinical trial in Brazil testing a high dose of chloroquine to treat
hospitalized COVID-19 patients was halted after a spike in deaths
among patients who received the drug.
The Brazilian trial, published on Friday in the Journal of the
American Medical Association Network Open, added to a pile of
confusing evidence around using the antimalarial pills chloroquine and
hydroxychloroquine for coronavirus patients.
There's no high-quality evidence showing the medicines help patients
with COVID-19, the disease caused by the coronavirus. The US Food and
Drug Administration said Friday these drugs should be used only in
clinical trials or at hospital because of safety risks to patients.
The National Institutes of Health has advised caution in prescribing
New York Gov. Andrew Cuomo said Thursday night that a review of
medical records by researchers at the State University of New York at
Albany showed that the drug "didn't really have much of an effect on
the recovery rate."
That conclusion came from a preliminary look at an observational study
of about 600 people. Data from the study hasn't been published or
reviewed by outside scientists, but Cuomo provided the information at
a CNN town hall broadcast. Cuomo's office didn't immediately respond
to requests for comment.
David Holtgrave, the dean of the Albany university's School of Public
Health and lead researcher on this study, said he hoped to complete
the analyses next week and would release detailed results in a
peer-reviewed manner as quickly as possible.