Invokana, Farxiga, and Similar Diabetes Drugs Effective, But Carry Genital Infection Risk: Study

Some patients have filed lawsuits indicating manufacturers failed to warn about the genital infection risk of the popular class of diabetes drugs.

According to the findings of a new study, there appears to be a more than two-fold increased risk of genital infections from Invokana, Farxiga and other medications that are part of the same new class of diabetes drugs.

Researchers from the U.K., China and Canada say sodium-glucose contransporter-2 (SGLT2) inhibitors provide protection from heart failure for those with type 2 diabetes, but warn that the drugs do not protect against kidney disease progression or kidney failure, and can increase the risk of severe genital infections, following reports of patients developing a flesh-eating groin infection known as necrotizing fasciitis, or Fournier’s gangrene. The findings were published in the Annals of Internal Medicine on April 12.

Invokana was the first member of this new class of medications to be approved by the FDA, in March 2013. Other drugs that are part of the same class of new-generation diabetes treatments include Farxiga, Jardiance, Glyxambi and Xigduo XR, which are all approved as second-line medications for type 2 diabetics.

Side effects of Invokana, Farxiga and other SGLT2 inhibitors have been linked to kidney failure risk, bone fracture risks and cases of Fournier’s gangrene, raising concerns about whether the health risks may outweigh the potential benefits.

In this latest study, researchers looked at eligible clinical trials involving patients with heart failure who were given SGLT2 inhibitors.

According to their findings, drugs like Invokana and Farxiga reduced hospitalization for heart failure by 37% after six months of use, and reduced cardiovascular death by 14% after a year. However, there was no indication the drugs protected against all-cause death, kidney disease progression or kidney failure.

The researchers also found the drugs more than doubled the risk of genetic infections.

“Among people with heart failure, SGLT2 inhibitors reduce hospitalizations for heart failure regardless of the presence of diabetes; absolute benefits are most pronounced in first-year treatment and vary with prognostic factors,” the researchers concluded. “Clinicians should note the increased risk for genital infections in patients receiving SGLT2 inhibitors.”

Over the last couple years, Farxiga in particular has faced a number of lawsuits over Fournier’s gangrene infections by former users of the diabetes drug, each raising similar allegations that users would have avoided the drug if earlier warnings and information had been provided about the potential risks.