SGLT2 inhibitors linked to rare but serious genital infection, FDA reports

Jack Woodfield
Wed, 08 May 2019
SGLT2 inhibitors linked to rare but serious genital infection, FDA reports
SGLT2 inhibitors are associated with an infection that develops in the genital area, although the risk is low, researchers say.

The US Food and Drug Administration (FDA) identified 55 cases linking SGLT2 inhibitors to Fournier gangrene (FG), an infection of the scrotum or the perineum (the area between the anus and the scrotum).

The type 2 diabetes drug class, SGLT2 inhibitors, comprises a group of tablets that are taken to help control blood glucose levels. These drugs work by helping the body to pass excess glucose out of the body through the urine.

These drugs have shown to be effective at improving blood glucose, supporting weight loss and enabling heart benefits. However, by passing excess glucose out via the urine, there is a greater risk of genitourinary infections - infections affecting the genitals and urinary system.

The cases were attained between March 2013 and January 2019. For comparisons, cases of FG were observed in people taking other diabetes medication from 1984-2019, with only 19 cases identified.

A team from FDA's Center for Drug Evaluation and Research has been investigating the claims and warned that if symptoms of the infections are ignored then "serious complications and death are likely".

The symptoms can be varied but usually include extreme pain, fatigue and fever. There may also be tenderness, erythema (redness of the skin) and swelling in the affected area.

The study authors wrote: "If FG were associated only with diabetes and not SGLT2 inhibitors, we would expect far more cases reported with the other antiglycemic agents, considering the 35-year timeframe and the large number of agents."

They have urged healthcare professionals to make people aware of the potential complications when they first prescribe the drugs.

They concluded: "Although the risk for FG is low, serious infection should be considered and weighed against the benefits of SGLT2 inhibitor therapy."

The prescribing information of all SGLT2 drugs was recently changed to reflect the possible risk of FG, as directed by the FDA.

The findings have been published in the journal Annals of Internal Medicine.
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