Serious Infection In The Genital Area Seems to Be A Drug Class Side Effect Of Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors
A new FDA analysis article published in May 2019 provides 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’s gangrene.
As we reported in this September 2018 article, “Newer Diabetes Drugs Side Effect: Fournier’s Gangrene, Serious Infection Of Genital Area”, the FDA had previously mandated a drug-class label change with new warnings about this adverse drug reaction, which is also known as necrotizing fasciitis of the perineum.
From the Abstract for “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, we get these details:
The FDA identified 55 unique cases of [Fournier gangrene (FG)] in patients receiving SGLT2 inhibitors between 1 March 2013 and 31 January 2019. The patients ranged in age from 33 to 87 years; 39 were men, and 16 were women. Time to onset after initiation of SGLT2-inhibitor therapy ranged from 5 days to 49 months. All patients had surgical debridement and were severely ill. Reported complications included diabetic ketoacidosis (n = 8), sepsis or septic shock (n = 9), and acute kidney injury (n = 4). Eight patients had fecal diversion surgery, 2 patients developed necrotizing fasciitis of a lower extremity that required amputation, and 1 patient required a lower-extremity bypass procedure because of gangrenous toes. Three patients died.
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Among the Fournier’s gangrene cases identified in this article, 21 cases were associated with Invokana (canagliflozin), 18 cases were associated with Jardiance (empagliflozin), and 16 cases were associated with Farxiga (dapagliflozin).
Lead author Susan Bersoff-Matcha, MD, of the FDA's Center for Drug Evaluation and Research in Silver Spring, Maryland, and her colleagues emphasized that clinicians should carefully watch patients on SGLT2 inhibitors for signs of Fournier’s gangrene. Further, they pointed out 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 summary, the FDA had previously added a warning about the increased risk of developing Fournier’s gangrene, also known as necrotizing fasciitis of the perineum, to the drug labels for all SGLT2 inhibitors in August 2018, based on 12 cases reported from March 2013 to May 2018. This new FDA analysis article presents findings from a review of 55 cases reported to the FDA Adverse Event Reporting System (FAERS) through January 2019.
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