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2 More Dings Against Drug: an FDA Warning and a Study

Agency cautions hydroxychloroquine should only be used in very restricted settings
By Jenn Gidman,  Newser Staff
Posted Apr 24, 2020 11:44 AM CDT

(Newser) – The drug once touted by President Trump as a possible "game changer" in the fight against the coronavirus has been the subject of more sobering headlines of late, and the newest one from the Food and Drug Administration doesn't help matters. Per Stat News, the FDA on Friday released a warning for health care providers on hydroxychloroquine and an older drug, chloroquine, both anti-malaria meds, cautioning that neither drug should be used to treat COVID-19 outside of a hospital setting or clinical trial. "We would like to remind health care professionals and patients of the known risks associated with both," the agency warned, noting it was aware of "increased use of these medicines through outpatient prescriptions." The agency cited "reports of serious heart rhythm problems" in virus patients who took the drugs, often with the antibiotic azithromycin or other medications.

Specifically, those heart issues include QT interval prolongation, which can cause heart arrhythmias, and ventricular tachycardia, which is a dangerously quick heart rate. Although the FDA has given the OK for the "temporary use" of these drugs for COVID-19 treatment in hospitalized patients in certain scenarios, it advises that "close supervision is strongly recommended," and only in the settings it has indicated. Meanwhile, New York Gov. Andrew Cuomo said Thursday that preliminary results on a hydroxychloroquine study that involved 600 subjects in the New York City area showed the drug didn't make it more likely that seriously ill COVID-19 patients survived, per the New York Post. "I think from the review that I heard basically it was not seen as a positive, not seen as a negative," Cuomo said during a CNN town hall. (Read more hydroxychloroquine stories.)

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