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What does Jardiance do to your perineum?

Medically reviewed by Melisa Puckey, BPharm. Last updated on April 3, 2024.

Official answer

by Drugs.com

Jardiance can increase the risk of having a rare, life-threatening bacterial infection that starts in the perineum, the area between the anus and either vagina or base of the penis. This severe infection is called necrotizing fasciitis or Fournier’s gangrene. It is caused by bacteria entering the layer of tissue just under the skin of the perineum, then may rapidly progress as infection and inflammation spreads to the superficial and deep tissues in the area.

Jardiance is used in certain patients with type 2 diabetes to lower blood sugar levels or to reduce the risk of cardiovascular problems, in adults with chronic kidney disease (CKD) to reduce the risk of disease progression, and also for specific adults with heart failure to lower the risk of cardiovascular death or being hospitalized with heart failure. Jardiance is from a class of medicines called SGLT2 inhibitors. It is from a class of medicines called SGLT2 inhibitors.

Why does Jardiance cause necrotizing fasciitis of the perineum?

Jardiance increases the risk necrotizing fasciitis due to they way it works. Jardiance helps the kidneys remove more sugar from your body through urination. This results in more sugar around your genital area which increases the amount of bacteria, as they feed on this extra sugar.

Bacteria can enter any broken or irritated skin and then infect the tissue beneath the skin, which can quickly spread and destroy tissue. It requires immediate treatment with antibiotics and surgery to remove the dead or dying tissue. Catching the infection early, before it spreads, is very important

Patients taking Jardiance or other SGLT2 inhibitors, including Invokana, Farxiga and Steglatro, should seek medical attention right away if a fever develops along with tenderness, redness or swelling in the genital area, as this may be a sign of Fournier’s gangrene.

Very few people get this rare infection, but research has found that the mortality rates of Fournier’s gangrene vary and can be quite high. The mortality rate can range from 20% to 50%, according to a study published in the World Journal of Emergency Surgery. Those who survive often require ongoing care after surgery to help heal wounds and recover function in their genital area.

One study found 55 cases of Fournier’s gangrene among people taking SGLT2 inhibitors between March 2013 and January 2019, which is almost triple the number of cases identified among patients taking other antidiabetic drugs between 1984 and January 2019. However, it’s hard to know if these cases were definitively caused by SGLT2 inhibitors, and the risk of getting Fournier’s gangrene while on these drugs remains low.

Other side effects of Jardiance:

Kidney problems and ketoacidosis are other rare and serious side effects of Jardiance.

Jardiance also has more common and treatable side effects, including yeast infections, urinary tract infections and increased urination.

This is not all the side effects of Jardiance, click here for more information on Jardiance side effects.

What is Jadiance is used for:

  • Helps control blood sugar in patients 10 years and older who have type 2 diabetes, when used together with diet and exercise.
  • Helps reduce the risk of disease progression in adults with chronic kidney disease (CKD).
  • For adults with heart failure Jardiance helps to reduce the risk of cardiovascular death and being hospitalized with heart failure.
  • For adults who have type 2 diabetes mellitus and established cardiovascular disease Jardiance is used to help reduce the risk of cardiovascular death.
References
  1. U.S. Food and Drug Administration (FDA). FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes. August 29, 2018. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-occurrences-serious-infection-genital-area-sglt2-inhibitors-diabetes. [Accessed August 11, 2020].
  2. Tenório CEL, Lima SVC, Albuquerque AV, Cavalcanti MP, Teles F. Risk factors for mortality in fournier's gangrene in a general hospital: use of simplified fournier gangrene severe index score (SFGSI). Int Braz J Urol. 2018 Jan-Feb;44(1):95-101. https://doi.org/10.1590/s1677-5538.ibju.2017.0193.
  3. Jaridance Package Insert. August 2021 [Accessed April 3, 2024]  https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s040lbl.pdf
  4. Benjelloun el B, Souiki T, Yakla N, et al. Fournier's gangrene: our experience with 50 patients and analysis of factors affecting mortality. World J Emerg Surg. 2013 Apr 1;8(1):13. doi: 10.1186/1749-7922-8-13.
  5. Bersoff-Matcha SJ, Chamberlain C, Cao C, Kortepeter C, Chong W. Fournier Gangrene Associated With Sodium-Glucose Cotransporter-2 Inhibitors: A Review of Spontaneous Postmarketing Cases. Ann Int Med. 2019 June 4;170(11)764-769. https://doi.org/10.7326/M19-0085.
  6. Jardiance Drug Approval History: https://www.drugs.com/history/jardiance.html
  7. Fournier Gangrene National Library of Medicine [Accessed April 3, 2024] https://www.ncbi.nlm.nih.gov/books/NBK549821/#:~:text=Fournier%20gangrene%20is%20a%20rare%20but%20deadly%20infection%20of%20the,area%20associated%20with%20significant%20pain.

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