Can Farxiga (dapagliflozin) cause gangrene?

From the Guidelines

Yes, Farxiga (dapagliflozin) can cause gangrene, specifically necrotizing fasciitis of the perineum, also known as Fournier's gangrene, although this is a rare and serious side effect 1.

Key Points

• The risk of Fournier's gangrene is rare, with only 12 cases reported over 5 years, with more than 1.7 million patients being prescribed SGLT2 inhibitors in 2017 1.
• Patients should be instructed to seek immediate medical attention if they experience signs or symptoms of ketoacidosis or Fournier's gangrene, such as pain or tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise 1.
• Daily hygienic measures may lessen the risk of genital mycotic infections, which are a known complication of SGLT2 inhibitors, and most genital mycotic infections are easily treated 1.
• The FDA has requested a warning to SGLT2 inhibitor prescribing instructions regarding the risk of Fournier's gangrene, although it is unclear whether these infections are causally related to SGLT2 inhibitor use 1.

Important Considerations

• Patients with a history of amputation, peripheral arterial disease, neuropathy, or diabetic foot ulcers should be monitored closely for signs of infection or ulceration 1.
• SGLT2 inhibitors may increase the risk of volume depletion and hypotension, and patients should be monitored for signs of hypovolemia, particularly when ill or fasting 1.
• The benefits of SGLT2 inhibitors, including Farxiga, in reducing the risk of cardiovascular events and kidney disease, should be weighed against the potential risks, and patients should be closely monitored for signs of adverse effects 1.

From the FDA Drug Label

5.5 Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene) Reports of necrotizing fasciitis of the perineum (Fournier’s Gangrene), a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in postmarketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors, including dapagliflozin

Yes, Farxiga (dapagliflozin) can cause a condition related to gangrene, specifically Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene), a rare but serious infection. 2

From the Research

Association between Farxiga (dapagliflozin) and Gangrene

• There have been reports of Fournier's gangrene (FG) in patients taking dapagliflozin, a sodium-glucose cotransporter 2 (SGLT-2) inhibitor 3, 4, 5, 6, 7.
• These cases suggest a possible association between dapagliflozin and FG, a rare but serious condition characterized by necrotizing fasciitis of the anogenital area 3, 6.
• The FDA has issued a black box warning about the risk of FG in patients taking SGLT-2 inhibitors, including dapagliflozin 6.
• Studies have reported that patients taking dapagliflozin may be at increased risk of genital infections, urinary tract infections, and FG 4, 5, 7.
• The exact mechanism of the association between dapagliflozin and FG is not fully understood, but it may be related to the increased risk of bacterial infections and glucosuria associated with SGLT-2 inhibitors 4, 7.

Clinical Implications

• Patients taking dapagliflozin should be monitored for signs and symptoms of FG, such as pain, swelling, and discharge in the anogenital area 3, 6.
• Healthcare providers should be aware of the potential risk of FG in patients taking dapagliflozin and take prompt action if symptoms occur 6, 7.
• Further research is needed to fully understand the relationship between dapagliflozin and FG, as well as to develop strategies for preventing and managing this rare but serious adverse effect 3, 7.