The FDA has identified 55 unique cases of Fournier gangrene associated with diabetes drugs in the Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors class between March 1, 2013 and January 31, 2019. Of those Fournier gangrene cases, 21 cases were associated with Invokana (canagliflozin), 18 cases were associated with Jardiance (empagliflozin), and 16 cases were associated with Farxiga (dapagliflozin).
This information comes from a new FDA analysis article, “Fournier Gangrene Associated With Sodium-Glucose Cotransporter-2 Inhibitors: A Review of Spontaneous Postmarketing Cases”, published in May 2019 by the medical journal Annals of Internal Medicine.
Lead author Susan Bersoff-Matcha, MD, of the FDA’s Center for Drug Evaluation and Research, and her colleagues emphasized that doctors should carefully watch patients on SGLT2 inhibitors for signs of Fournier gangrene. Further, they made this important point in their article: “Serious complications and death are likely if [Fournier gangrene (FG)] is not recognized immediately and surgical intervention is not carried out within the first few hours of diagnosis.”
In August 2018 the FDA added a warning about the increased risk of developing Fournier gangrene, also known as necrotizing fasciitis of the perineum, to the drug labels for all SGLT2 inhibitors, based on 12 cases reported from March 2013 to May 2018. Now, with this May 2019 medical journal article, there is more evidence that a class of diabetes drugs which includes Invokana, Jardiance, and Farxiga can cause a serious infection in the genital area known as Fournier gangrene.[View article at original source]
Strictly Confidential, No Obligation