Necrotizing Faciitis of the Perineum Linked as Side Effect of SGLT2 Inhibitor Drugs
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Diabetes drugs in the sodium-glucose cotransporter 2 (SGLT2) inhibitors class are associated with Fournier's Gangrene, or necrotizing fasciitis of the perineum. Drugs within this class include, but are not limited to, Invokana (canaglifozin), Jardiance (empaglifozin), and Farxiga (dapagliflozin).
History of SGLT2 Drugs and Fournier's Gangrene
According to an August 29, 2018, Drug Safety Communication, "FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes”:
Fournier’s gangrene is an extremely rare but life-threatening bacterial infection of the tissue under the skin that surrounds muscles, nerves, fat, and blood vessels of the perineum....
In the five years from March 2013 to May 2018, we identified 12 cases of Fournier’s gangrene in patients taking an SGLT2 inhibitor...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.
Similarly, a May 2019 FDA analysis article provides more evidence of Fournier's gangrene in association with SGLT2 Inhibitor diabetes drugs. The article, published by the medical journal Annals of Internal Medicine, entitled "Fournier Gangrene Associated With Sodium-Glucose Cotransporter-2 Inhibitors" states:
The FDA identified 55 unique cases of FG in patients receiving SGLT2 inhibitors between 1 March 2013 and 31 January 2019... Time to onset after initiation of SGLT2-inhibitor therapy ranged from 5 days to 49 months. All patients had surgical debridement and were severely ill...
FG 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.
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Moving Forward and Potential Legal Action
The FDA is currently advising patients to seek immediate medical attention if they are experiencing symptoms of Fournier's gangrene. According to the August 29, 2018, Drug Safety Communication, "FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes”:
Patients should seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away.
Health care professionals should assess patients for Fournier’s gangrene if they present with the symptoms described above. If suspected, start treatment immediately with broad-spectrum antibiotics and surgical debridement if necessary. Discontinue the SGLT2 inhibitor, closely monitor blood glucose levels, and provide appropriate alternative therapy for glycemic control.
We will continue to monitor the current drug safety issue of Fournier's gangrene in relation to patients using SGLT2 inhibitor drugs such as Invokana, Jardiance and Farxiga. We are currently evaluating Fournier's Gangrene cases and possible drug injury lawsuits against the responsible pharmaceutical companies.
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