Study warns of flesh-eating genital infection linked to diabetes drugs

May 9, 2019

A new study echoes a previous FDA warning about the link between Type 2 diabetes drugs known as SGLT2 inhibitors and the genital infection called Fournier gangrene (FG).

The infection, a necrotizing fasciitis, is rare but life-threatening. Last August, the FDA announced that a new warning about this risk needed to be added to the prescribing information of all SGLT2 inhibitors. First approved in 2013, medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin — manufactured by Johnson & Johnson, AstraZeneca, Eli Lilly and Boehringer Ingelheim.

In the new study, published in the peer-reviewed Annals of Internal Medicine, researchers used data from the FDA's Adverse Event Reporting System. They found that the FDA identified 55 unique cases of FG in patients receiving SGLT2 inhibitors between March 1 2013 and January 31, 2019. All patients had surgical debridement and were severely ill; three died.

The study concluded that "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."