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FDA warns of rare genital infection associated with SGLT2 inhibitors for diabetes
The FDA issued a drug safety communication for health care providers and the public today following reports of necrotizing fasciitis of the perineum, also known as Fournier’s gangrene, in people prescribed drugs in the SGLT2 inhibitor class of diabetes medications.
The statement referred to the condition as “rare but serious” and advises patients taking the agents to seek immediate medical help if they experience “any symptoms of tenderness, redness or swelling of the genitals or the area from the genitals back to the rectum” together with a fever above 100.4 F. Health care providers are advised to initiate treatment immediately with broad-spectrum antibiotics and surgical debridement, if needed, and discontinue SGLT2 therapy.
The FDA will require prescribing information of all medications containing SGLT2 inhibitors to include the new safety warning. Currently approved SGLT2 inhibitors include canagliflozin (Invokana, Janssen), dapagliflozin (Farxiga, AstraZeneca), empagliflozin (Jardiance, Boehringer Ingelheim/Lilly) and ertugliflozin (Steglatro, Merck).
Read the safety alert at www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm618908.htm.
Perspective
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SGLT-2 inhibitors are a highly favored class of anti-diabetic therapies, two of which have been shown to reduce cardiovascular events and, in one case, CV mortality. There have been scattered reports of lower limb ischemia and/or amputation with these agents. The mechanisms by which this occurs is unclear. We are now faced with cases of ischemia more central than those reported in the past. Again, the mechanism of this complication remains unknown as is the clinical implication of this finding. This is yet another complication of drug therapy which must be explained to and anticipated by patients. It is not likely to improve patient compliance, but they should be cautioned about it.
Baylor College of Medicine