In a new study, researchers found that people who are taking a newer class of medications to treat type 2 diabetes may experience pain, redness and a foul odor in the genital area.
This is a disease called Fournier gangrene. This infection attacks the genital or anal region and can quickly kill tissue as it spreads rapidly.
The newer drugs are SGLT2 inhibitors.
SGLT2 inhibitors are a newer class of diabetes medications, introduced in 2013. Drugs in this class include canagliflozin (Invokana), dapagliflozin (Farxiga) and empagliflozin (Jardiance).
SGLT2 inhibitors work in the kidneys, allowing excess blood sugar to be removed in the urine.
In addition to lowering blood sugar levels, the drugs may also reduce the risk of heart disease and stroke in some people with type 2 diabetes.
But possible side effects include urinary tract infections and genital infections, such as yeast infections. Kidney problems can also be a concern with this class of medications.
The disease Fournier gangrene occurred in 55 people taking these drugs between March 2013 and January 2019.
All of the patients with the disease identified in this study needed to be hospitalized. Some had several surgeries. Three of the 55 people died from Fournier gangrene.
For comparison, the researchers looked for cases of Fournier gangrene in people taking other diabetes medications from 1984 to 2019. They found only 19 such cases.
Still, the risk for Fournier gangrene remains very low.
While the study shows an association between treatment with SGLT2 inhibitors and Fournier gangrene, researchers don’t know exactly what the risk is, or if Fournier gangrene can be predicted.
Broad-spectrum antibiotics and surgery to remove the dead tissue are treatment options for the disease.
Researchers say that a far bigger concern is uncontrolled diabetes and the risk of complications when blood sugar levels aren’t controlled. The benefits of these medications outweigh the risks.
The prescribing information of all SGLT2’s was recently changed to reflect the possible risk of Fournier gangrene, as directed by the FDA.
One author of the study is Dr. Susan Bersoff-Matcha, a medical officer in the FDA’s Center for Drug Evaluation and Research.
The study is published in the Annals of Internal Medicine.
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