Product News and Recalls

Diabetes Drug Linked to Flesh-Eating Genital Infection

sglt2 inhibitors linked to flesh-eating genital infectionDiabetic patients taking Invokana, Farxiga, or Jardiance are on alert over reports that these SGLT2 inhibitors could possibly cause a potentially lethal flesh-eating infection of the genitals. Bloomberg recently reported that SGLT2 inhibitor-induced Fourneir’s gangrene was observed in a dozen patients between March 2013 and May 2018. All cases required surgery and in one case the condition proved fatal. The FDA has said that more cases could be discovered once the risk, as it pertains to these particular medications, is better understood.

When compared to non-SGLT2 inhibitor-based drugs, only six cases of the condition could be identified over the course of 30 years. A separate SGLT2 inhibitor – Steglugan – has not been linked to the infection. However, Steglugan is new. In fact, it is the newest SGLT2 inhibitor on the market having been approved for use in December of last year.

SGLT2 inhibitors work by aiding the body’s efforts in controlling blood-sugar levels and forcing excess sugars out in the patient’s urine. While urinary tract infections are a known side effect of the medications, other side effects and adverse reactions have come to light. One such medication, Invokana, has been linked to a condition known as diabetic ketoacidosis, or a buildup of acid in the blood. Diabetic ketoacidosis can be life threatening if not treated promptly and can also lead to swelling in the brain and the onset of a diabetic coma.

Fournier’s gangrene can develop and worsen quickly and patients are being told to seek immediate medical attention in the event that they develop any redness, swelling, or tenderness in their genitals while taking the medication and if those symptoms are accompanied even the slightest of fevers. In the meantime, the drugs will have information related to Fournier’s gangrene added to their product safety information and to the guides given to patients.

While caution and awareness of the condition are important facets of any aspect of patient safety, it’s also important to note that about 1.7 million patients were written for SGLT2 inhibitors in 2017. This makes Fournier’s gangrene induced by SGLT2 inhibitors an incredibly rare condition. Still, the possibility of contracting such an infection is not one to be taken lightly and patients should remain vigilant.