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 Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetesFDA Drug Safety Podcasts FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes
  
  	
    Share
    Post
    Linkedin

    Email
    PrintListen

Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information. This is Lesley Navin, Advanced Practice Nurse.

On August 29, 2018, FDA warned that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (or SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. We are requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. They lower blood sugar by causing the kidneys to remove sugar from the body through the urine. Medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin.

Health care professionals should assess patients for Fournier’s gangrene and if suspected, start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary. Discontinue the SGLT2 inhibitor, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.

Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum. Published literature about the occurrence of Fournier’s gangrene for men and women is limited, with reported occurrence in 1.6 out of 100,000 males annually in the U.S., most frequently in males 50-79 years of age.

From March 2013 to May 2018, we identified 12 cases, 7 men and 5 women, of Fournier’s gangrene in patients taking an SGLT2 inhibitor. This includes only reports submitted to FDA and found in the medical literature, so there may be additional cases about which we are unaware. Fournier’s gangrene developed within months of patients starting an SGLT2 inhibitor. All 12 patients were hospitalized and required surgery. In comparison, only six cases of Fournier’s gangrene (all in men) were identified in review of other antidiabetic drug classes over a period of more than 30 years.

Side effects involving SGLT2 inhibitors should be reported to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals and the complete data summary can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

Thank you for listening.

Related Information

FDA Drug Safety Communication: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes
	FDA Drug Safety Podcast: FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes

                                                                                  Content current as of:
      01/11/2022FDA 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