New warnings this month from researchers on the risk of a rare flesh-eating bacteria linked to a class of popular type 2 diabetes drugs. Last year, the Food & Drug Administration added new language to the labels of Invokana, Farxiga and Jardiance on the risk of Fournier's gangrene, a rare form of flesh-eating bacteria that affects the genitals. Now, new research out of the FDA's Center for Drug Evaluation and Research has added fuel to the fire, increasing scrutiny on the risk-benefit profile.
In a paper published by the Annals of Internal Medicine, authors from the FDA say patients taking SGLT2 inhibitors - a class of medications that includes Invokana, Farxiga and Jardiance - suffered from at least 55 cases of Fournier's gangrene between March 1, 2013 and January 31, 2019. The data was made available through the FDA's adverse event reporting database and includes information from 39 men and 16 women.
Fournier's gangrene is exceedingly rare and exceedingly dangerous. Among the SGLT2 inhibitor patients reviewed by the FDA, three died, while eight were required to undergo fecal diversion surgery. Another two developed flesh-eating bacteria infections in their lower limbs requiring amputation procedures. All of the 55 patients were required to undergo at least some measure of surgical intervention to remove dying tissue. The patients were classified as "severely ill."
This isn't the first time that the FDA has analyzed cases of Fournier's gangrene but it may well be the most pronounced study to date. To provide a comparison to the SGLT2 inhibitor cases, the researchers reviewed cases of Fournier's gangrene between 1984 and 2019 for other types of diabetes drugs. The FDA found 19 additional cases in total for patients who were taking metformin, insulin glargine, short-acting insulin, Januvia plus metformin and Trulicity. While two of these patients tragically died, the other drugs do not seem to present the same risk of genital gangrene as do Jardiance, Farxiga and Invokana.
While the researchers are careful to advise that no firm link of causality can be made in the case, other observers have proposed a theory to explain why cases of Fournier's gangrene appear to be higher among patients on SGLT2 inhibitors. Jardiance, Farxiga and Invokana treat type 2 diabetes by increasing the amount of sugar secreted through the urine. In some cases, this mechanism of action appears to make the genitals more "sugary," perhaps increasing the likelihood of an infection. Fournier's gangrene often develops after a patient contracts a urinary tract or bladder infection, which may be more likely after the genitals have been inundated by sugary liquids, including urine.
In conclusion, the FDA researchers write, "Fournier's gangrene is a newly identified safety concern in patients receiving SGLT2 inhibitors. Physicians prescribing these agents should be aware of this possible complication and have a high index of suspicion to recognize it in its early stages." Patients who have developed Fournier's gangrene can display a variety of symptoms, including:
Were you or a loved one diagnosed with Fournier's gangrene after taking Farxiga, Jardiance or Invokana? Our experienced personal injury attorneys are here to help. You may be entitled to significant financial compensation. Our lawyers are currently investigating allegations that the manufacturers of these drugs knew about these risks but failed to warn the public. Legal action may be possible. Don't hesitate to reach out for help. Learn more in a free, confidential consultation.