FDA updates SGLT2 inhibitor labelling: enhanced Fournier's gangrene warning
FDA updated labelling for all SGLT2 inhibitors (empagliflozin, dapagliflozin, canagliflozin, ertugliflozin) to include enhanced warnings about Fournier's gangrene (necrotising fasciitis of the perineum) — a rare but life-threatening infection. The update adds specific guidance on risk factors, early recognition signs, and the need for immediate discontinuation and surgical assessment.
FDA updated labelling for all marketed SGLT2 inhibitors — empagliflozin (Jardiance) ↗, dapagliflozin (Farxiga) ↗, canagliflozin (Invokana), and ertugliflozin (Steglatro) — on 6 October 2026 to include enhanced Fournier's gangrene warnings. The updated labelling specifies: risk factors for the condition, early recognition signs (pain, swelling, erythema of the perineum with fever), the requirement to immediately discontinue the SGLT2 inhibitor and initiate broad-spectrum antibiotics and urgent surgical consultation.
About Fournier's gangrene (necrotising fasciitis of the perineum)
Fournier's gangrene (NCBI) ↗ is a polymicrobial necrotising fasciitis of the perineum and genital region. It is rare but has a case-fatality rate of 20–40%. Risk factors include diabetes mellitus, obesity, immunosuppression, and urogenital instrumentation. The mechanism by which SGLT2 inhibitors may predispose to Fournier's gangrene is thought to relate to glucosuria creating a favourable environment for polymicrobial perineal infection, combined with the immunomodulatory effects of glycaemic flux. Initial FDA safety communication was issued in 2018 ↗; this 2026 update reflects accumulated post-market surveillance data.
SGLT2 inhibitor benefit-risk context
Despite this safety update, SGLT2 inhibitors retain a highly favourable overall benefit-risk profile. Major outcomes trials establish significant reductions in cardiovascular death (EMPA-REG OUTCOME, DAPA-HF), hospitalisation for heart failure, and progression of CKD (CREDENCE, DAPA-CKD, EMPA-KIDNEY). The KDIGO Diabetes-CKD guidelines ↗ and ACC Heart Failure guidelines ↗ maintain SGLT2 inhibitors as first-line agents. The absolute risk of Fournier's gangrene is estimated at approximately 1–3 cases per 10,000 patient-years. Pharmacists should counsel patients to report any perineal pain, redness, or fever immediately.
Patient counselling points
When dispensing SGLT2 inhibitors, pharmacists and prescribers should advise patients: maintain good genital hygiene; report immediately any pain, warmth, tenderness, or swelling in the genitals or perineum — especially if accompanied by fever or malaise; do not delay seeking care as Fournier's gangrene progresses rapidly. The FDA safety information portal ↗ has a patient-facing fact sheet. All adverse events should be reported via FDA MedWatch ↗.
FAQ
Does a Boxed Warning mean a drug is being withdrawn?
No. A Boxed Warning ↗ (also called a Black Box Warning) is the FDA's strongest label caution, but the drug remains on the market. It means the agency has determined that a risk is serious enough to require prominent, standardised labelling. The drug continues to be prescribed under appropriate clinical conditions. See the FDA's patient guide to Boxed Warnings ↗.
Where can I read the full updated label?
All current FDA-approved prescribing information is available on DailyMed ↗, maintained by the National Library of Medicine (NLM). Search by drug name to find the most recent label version. Historical label versions are also archived there.