A new review of Fournier Gangrene cases associated with SGLT2 diabetes drugs conducted by researchers is shedding new light on the occurrence of the rare disease, and offering new numbers and warnings for doctors prescribing the drugs.
Last year, the FDA stated it would require a new warning about the risk of contracting the flesh-eating bacterial infection of the genitals on all SGLT2 inhibitors and to the patient Medication Guide.
In the most recent review published in the Annals of Internal Medicine, researchers found patients taking SGLT2 drugs suffered from 55 unique cases of Fournier’s gangrene.
The cases were recorded between March 1, 2013, and January 31, 2019. The researchers collected data from the FDA’s adverse event reporting database. Thirty-nine patients were men and 16 were women.
The patients ranged in age from 33 to 87 years old. 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 with various reported complications. 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, according to the data.
For comparison, they also looked at Fournier’s cases between 1984 and January 31, 2019, in which the FDA tracked 19 cases during that time frame for patients on metformin, insulin glargine, short-acting insulin, sitagliptin plus metformin, and dulaglutide.
These patients ranged in age from 42 to 79 years; 12 were men, and 7 were women. Two patients died.
The researchers say the current review has several limitations, namely that they are unable to “establish causality or incidence, variable quality of reports, possible underreporting, and confounding by indication.”
However, they conclude Fournier Gangrene is a newly identified safety concern in patients receiving SGLT2 inhibitors.
“Physicians prescribing these agents should be aware of this possible complication and have a high index of suspicion to recognize it in its early stages,” they note.
No funding source for the study has been disclosed.
- Annals of Internal Medicine. Fournier Gangrene Associated With Sodium-Glucose Cotransporter-2 Inhibitors: A Review of Spontaneous Postmarketing Cases. (2019, May 7). Retrieved: https://annals.org/aim/article-abstract/2732837/fournier-gangrene-associated-sodium-glucose-cotransporter-2-inhibitors-review-spontaneous