April 25, 2020
The Food and Drug Administration (FDA) issued a safety warning yesterday addressing the efficacy of two malaria drugs that have often been recommended by President Trump during the White House Coronavirus Press Briefings. President Trump has frequently recommended the use of these drugs despite statements from experts that evidence of their effectiveness against Coronavirus is lacking.
Hydroxychloroquine and chloroquine are FDA-approved specifically to treat Malaria. Hydroxychloroquine is also FDA-approved for certain autoimmune conditions.
The notice draws attention to the “facts” that “hydroxychloroquine or chloroquine can cause abnormal heart rhythms such as QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia.” The risks may increase when these drugs are taken in combination with other medications known to prolong the QT interval, such as azithromycin, a drug also being used to treat COVID-19 patients without FDA approval.
As stated by the notice,
Hydroxychloroquine and chloroquine can cause abnormal heart rhythms such as QT interval prolongation and a dangerously rapid heart rate called ventricular tachycardia. These risks may increase when these medicines are combined with other medicines known to prolong the QT interval, including the antibiotic azithromycin, which is also being used in some COVID-19 patients without FDA approval for this condition. Patients who also have other health issues such as heart and kidney disease are likely to be at increased risk of these heart problems when receiving these medicines.
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To decrease the risk of these heart problems that can be life-threatening, we are warning the public that hydroxychloroquine and chloroquine, either alone or combined with azithromycin, when used for COVID-19 should be limited to clinical trial settings or for treating certain hospitalized patients under the EUA. FDA will continue to investigate risks associated with the use of hydroxychloroquine and chloroquine for COVID-19, and we will communicate publicly when we have more information
The FDA Drug Safety Communication, dated April 24, 2020, stated that prescriptions for use of these anti-malarial drugs for COVID-19 have increased through outpatient prescriptions. The notice serves as a reminder to health care professionals and patients of the known risks of the drugs.