The FDA has issued guidance reinforcing what it said in March: the malaria drugs hydroxychloroquine and chloroquine should only be used to treat COVID-19 patients when they are hospitalized and participation in a clinical trial is "not available," or "not feasible."
The FDA originally granted Emergency Use Authorization (EUA) for the medicines on March 28 but emphasized at the time it was under the same restrictions.
In an April 24 update, the FDA stated it is "aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT-prolonging medicines. We are also aware of increased use of these medicines through outpatient prescriptions."
If a healthcare professional is considering use of hydroxychloroquine or chloroquine to treat or prevent COVID-19, FDA recommends checking www.clinicaltrials.gov for a suitable clinical trial and consider enrolling the patient.FDA statement, April 24
President Trump has stated that there were some promising signals, and that if the malaria medicines turn out to be effective against coronavirus without major side effects, it could be a "game changer." He said "we'll have to wait and see" if it is the solution many hope for.
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