FDA issues new warning regarding SGLT2 inhibitors after 12 cases of rare necrotizing fasciitis, Fournier’s Gangrene, emerge.
On August 29, 2018, the FDA issued a warning regarding SGLT2 inhibitors being linked to a rare, but serious, necrotizing fasciitis infection. The statement issued by the FDA specified that this warning is now required to be added to the medication guide in the prescribing information for all SGLT2 inhibitors.
SGLT2 inhibitors are a class of oral glucose-lowering agents approved for use in type 2 diabetes since 2013. This class of medication works via promotion of renal excretion of glucose to lower blood glucose levels. SGLT2 inhibitors include agents such as canagliflozin, dapagliflozin, ertugliflozin and empagliflozin, among others, and are commonly prescribed for both initial management and maintenance of type 2 diabetes.
“Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum,” explains the FDA announcement. “The bacteria usually get into the body through a cut or break in the skin, where they quickly spread and destroy the tissue they infect.”
People with diabetes are at an increased risk of developing this type of infection, compared to those without diabetes, even if they aren’t taking an SGLT2 inhibitor. That’s because excess glucose in the bloodstream and urine feeds infection and impairs the healing process of even small cuts or blisters.
However, experts emphasize how rare the likelihood is of a patient developing this infection by taking SGLT2 inhibitor medications. With seven cases out of 7 million prescriptions, that makes it literally a one-in-a-million event.
The FDA report explains that between March 2013 to May 2018, there were 12 cases of Fournier’s gangrene in patients taking a SGLT2 inhibitor medication. “Fournier’s gangrene developed within several months of the patients starting an SGLT2 inhibitor and the drug was stopped in most cases,” the report states. “All 12 patients were hospitalized and required surgery. Some patients required multiple disfiguring surgeries, some developed complications, and one patient died.” The report adds that in patients taking other diabetes medications, there have only been six cases of Fournier’s gangrene reported, all of which were in men, over the course of 30 years. Of the 12 reported in this recent report, seven were men and five were women.
It is important to understand that Fournier’s gangrene aside, any medication purposefully passing glucose through the urine raises the risk for all types of infection, especially basic urinary tract infections (UTIs). Patients need to be made aware and to be on the lookout for signs of UTI and seek treatment. It should never get to a point as serious as gangrene.
Fournier’s gangrene often is seen infecting the scrotum and penis and can lead to amputation and tissue removal in serious cases. Most often, Fournier’s gangrene occurs when a skin wound brings bacteria or other organisms into the bloodstream where they can ultimately spread to deeper tissues and cause inflammation and tissue death.
The FDA is urging anyone taking SGLT2 inhibitors to seek immediate medical attention if symptoms of Fournier’s gangrene arise, such as “tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum.” Additionally, if patients experience fevers greater than 100.4 F or other general signs of infection, they should notify a healthcare professional and seek treatment.
- The FDA has required a new warning about the risk of Fournier’s gangrene to be added to the Medication Guide for all SGLT2 inhibitors.
- 12 reported cases of Fournier’s gangrene have been linked to SGLT2 inhibitor use in the past five years.
- Prior to 2013, only 6 cases of Fournier’s gangrene had been reported since 1984.
- Fournier’s gangrene is a potentially life-threatening form of necrotizing fasciitis and the FDA is urging anyone with symptoms to seek immediate medical attention.
Center for Drug Evaluation and Research. (2018, August 29). Drug Safety and Availability – FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm617360.htm
Tucker, M. E. (2018, August 29). FDA Warns of Serious Genital Infection With SGLT2 Inhibitors. Retrieved from https://www.medscape.com/viewarticle/901365
DeSantis, Anthony MD. Sodium-glucose co-transporter 2 inhibitors for the treatment of type 2 diabetes mellitus. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com (Accessed on August 30, 2018.)
Clarke Powell, Pharm.D. Candidate 2019, LECOM School of Pharmacy
For more about SGLT2 inhibitors, visit our therapy center.