Northerner
Admin (Retired)
- Relationship to Diabetes
- Type 1
Fournier gangrene (FG), a necrotizing infection of the perineum, is a relatively rare but potentially fatal complication of treatment with sodium-glucose cotransporter-2 (SGLT2) inhibitors, new data from the US Food and Drug Administration (FDA) suggest.
The FDA had previously added a warning about FG to the labels of all SGLT2 inhibitors, used to treat type 2 diabetes, in August 2018, based on 12 cases reported from March 2013 to May 2018.
Now, findings from a review of 55 cases reported to the FDA Adverse Event Reporting System (FAERS) through January 2019 have been published onlineMay 6 in Annals of Internal Medicine by Susan J. Bersoff-Matcha, MD, of the FDA's Center for Drug Evaluation and Research, Silver Spring, Maryland, and colleagues.
All of the patients required hospitalization, some needed multiple surgeries, and there were three fatalities.
https://www.medscape.com/viewarticle/912634
Very rare, but worrying
The FDA had previously added a warning about FG to the labels of all SGLT2 inhibitors, used to treat type 2 diabetes, in August 2018, based on 12 cases reported from March 2013 to May 2018.
Now, findings from a review of 55 cases reported to the FDA Adverse Event Reporting System (FAERS) through January 2019 have been published onlineMay 6 in Annals of Internal Medicine by Susan J. Bersoff-Matcha, MD, of the FDA's Center for Drug Evaluation and Research, Silver Spring, Maryland, and colleagues.
All of the patients required hospitalization, some needed multiple surgeries, and there were three fatalities.
https://www.medscape.com/viewarticle/912634
Very rare, but worrying