Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                FDA Drug Safety Podcasts

FDA Drug Safety Podcasts Home
          Drugs
          Drug Safety and Availability
          FDA Drug Safety Podcasts
          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 problemsFDA Drug Safety Podcasts 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
	
    Share
    Post
    Linkedin

    Email
    PrintListen

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 druginfo@fda.hhs.gov  and follow us on Twitter @FDA_Drug_Info.

Related Information

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

                                                                                  Content current as of:
      01/12/2022
              
              
Regulated Product(s)
		 DrugsFDA Drug Safety Podcasts
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop