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Regulatory Focus™ > News Articles > 2020 > 4 > FDA warns against malaria drugs for COVID-19 outside hospital, clinical settings

FDA warns against malaria drugs for COVID-19 outside hospital, clinical settings

Posted 24 April 2020 | By Michael Mezher 

FDA warns against malaria drugs for COVID-19 outside hospital, clinical settings

The US Food and Drug Administration (FDA) on Friday warned against the use of malaria drugs hydroxychloroquine and chloroquine to treat coronavirus disease (COVID-19) outside hospitals or clinical trials due to serious heart risks.
FDA says it is “aware of reports of serious heart rhythm problems,” including deaths in COVID-19 patients treated with the drugs, either alone or in combination with other QT-prolonging drugs such as azithromycin, and warns that patients with heart and kidney disease may be at higher risk.
The agency says it reviewed case reports in its FDA Adverse Event Reporting System (FAERS) database, published medical literature and the American Association of Poison Control Centers National Poison Data System and found reports describing “QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases death,” from both hospital and outpatient settings.
The warning comes after FDA took the unusual step of granting an emergency use authorization (EUA) allowing the drugs to be used to treat hospitalized COVID-19 patients who are unable to participate in clinical trials.
Hydroxychloroquine and chloroquine have also been championed by President Donald Trump as potential “game changers” in the fight against COVID-19, despite little evidence to support their safety or efficacy in treating the disease, though he has since dialed back his promotion of the drugs.
Several small studies have found little to no benefit from the drugs and the National Institutes of Health (NIH) this week said there is “insufficient clinical data to recommend either for or against using chloroquine or hydroxychloroquine for the treatment of COVID-19.” Numerous clinical trials investigating the use of both drugs are planned or underway, including studies organized by the World Health Organization, NIH and Novartis.
As a result of the risks, FDA says the drugs should only be used under the EUA or in clinical trials, and that patients treated with the drugs require “close supervision,” including monitoring baseline ECG, electrolytes, and renal and hepatic function.
“While clinical trials are ongoing to determine the safety and effectiveness of these drugs for COVID-19, there are known side effects of these medications that should be considered. We encourage health care professionals making individual patient decisions closely screen and monitor those patients to help mitigate these risks,” said FDA Commissioner Stephen Hahn.
FDA, Statement

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