UPDATE: (May 2019) – A new study published May 6th in the journal Annals of Internal Medicine, indicates the risk of developing “Fournier’s gangrene” from taking SGLT-2 Inhibitors is greater than initially believed. The researchers, examining information from the FDA’s Adverse Reporting System, discovered “Fournier’s gangrene” occurred in 55 people taking SGLT-2 Inhibitors (Invokana, Farxiga & Jardiance) between March 1, 2013, and January 31, 2019 – a period of 6 1/2 years. In comparison, researchers found only 19 cases of the disease in people taking other diabetes medications between 1984 and January 31, 2019 – a period of 35 years. The time from initiation of treatment with a SGLT-2 Inhibitor to onset of the condition ranged from 5 days to 49 months. This is a much larger number of cases than the 12 which led the FDA to issue a warning about last fall. Each patient had to undergo surgical debridement and were considered “severely ill”.
“Fournier’s gangrene” can cause extreme pain in the scrotum, penis, vulva, vagina, or anal areas, as well as fever and a general, overall feeling of fatigue and illness. The affected area may appear red, emit a foul odor, and become gangrenous causing tissue to die. If left untreated, “Fournier’s gangrene” can spread to the thighs, into the abdominal wall, and up to the chest. The condition is generally treated with broad-spectrum antibiotics to kill the infection, and surgery to remove dead tissue.
If you or a loved one were diagnosed with “Fournier’s gangrene” after taking Invokana, Jardiance or Farxiga, contact us online or call us at 1-866-252-3535.
UPDATE: (Aug. 2018) – The U.S. Food & Drug Administration has released an official “risk warning” regarding a rare but extremely serious, life-threatening condition associated with SGLT-2 Inhibitors, including Invokana, Jardiance, and Farxiga.
“In the five years from March 2013 to May 2018, we identified 12 cases of Fournier’s gangrene in patients taking an SGLT2 inhibitor…. Although most cases of Fournier’s gangrene have previously been reported in men, our 12 cases included 7 men and 5 women. … . All 12 patients were hospitalized and required surgery. Some patients required multiple disfiguring surgeries, some developed complications, and one patient died. In comparison, only six cases of Fournier’s gangrene (all in men) were identified in review of other antidiabetic drug classes over a period of more than 30 years.”
“Fournier’s gangrene” is an necrotizing infection that affects the tissue, muscles, fat, nerves and blood vessels of the perineum; the area around/between the genitals and the rectum. The condition can quickly worsen and result in death. According to the FDA, the patients had been taking SGLT2 inhibitors for an average of 9.2 months before onset of the infection.
If you or a loved one were hospitalized for renal failure, ketoacidosis, suffered a heart attack or stroke, required a leg, foot or toe amputation, or been diagnosed with “Fournier’s gangrene” while taking Invokana, Jardiance or Farxiga, contact us online or call us at 1-866-252-3535.
Do not stop taking any medication without consulting your healthcare provider.