Welcome to the FDA Drug Safety Podcast for health care professionals.
On April 24, 2020 FDA announced that we are 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. We are reminding health care professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine.
Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19. They are being studied in clinical trials for COVID-19, and we authorized their temporary use during the COVID-19 pandemic for treatment of the virus in hospitalized patients when clinical trials are not available, or participation is not feasible, through an Emergency Use Authorization (or EUA). The medicines being used under this EUA are supplied from the Strategic National Stockpile, the national repository of critical medical supplies to be used during public health emergencies. This safety communication reminds physicians and the public of risk information set out in the hydroxychloroquine and chloroquine healthcare provider fact sheets that were required by the EUA.
Hydroxychloroquine and chloroquine can cause abnormal heart rhythms such as QT interval prolongation and ventricular tachycardia. These risks may increase when these medicines are combined with other medicines known to prolong the QT interval, including azithromycin.
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.
Hydroxychloroquine and chloroquine are FDA-approved to treat or prevent malaria. Hydroxychloroquine is also FDA-approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis.
The EUA was based upon limited evidence that the medicines may provide benefit, and for this reason, we authorized their use only in hospitalized patients under careful heart monitoring. 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.
We reviewed case reports in the FDA Adverse Event Reporting System database, the published medical literature, and the American Association of Poison Control Centers National Poison Data System. These adverse events were reported from hospital and outpatient settings for treating or preventing COVID-19, and included QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases death. We are continuing to investigate these safety risks in patients with COVID-19 and will communicate publicly when more information is available.
Side effects involving hydroxychloroquine and chloroquine should be reported to the FDA MedWatch program at www.fda.gov/medwatch.
A link to the full communication detailing specific information for health care professionals can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at firstname.lastname@example.org and follow us on Twitter @FDA_Drug_Info.
- FDA Drug Safety Communication: FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems
- FDA Drug Safety Podcast: FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems