Diabetes Drug Gangrene Lawsuit

Serious Genital Infections

Serious genital infections have been reported with the class of type 2 diabetes drugs called sodium-glucose cotransporter-2 (SGLT-2) inhibitors.  The infection is called necrotizing fasciitis of the perineum, and is also referred to as Fournier’s gangrene.  The FDA warned on August 29, 2018 that some diabetes drugs can cause this infection and lead to painful surgery.  The FDA warning includes the diabetes drugs Invokana, Invokamet, Farxiga, Jardiance, and Steglatro.

 

 

The FDA action requires the makers of these drugs to add a new warning about this serious risk to the prescribing information of all SGLT2 inhibitors, as well as to the patient Medication Guide.
SGL-2 Inhibitors

The FDA first approved SGLT2 inhibitors  — sodium-glucose cotransporter-2 — in 2013 to help lower blood sugar in adults with type 2 diabetes.  These drugs lower blood sugar by causing the kidneys to remove sugar through the urine.  The SGLT2 inhibitor class of medicines includes canagliflozin (Invokana), dapagliflozin (Farxiga), empagliflozin (Jardiance), and ertugliflozin (Steglatro).  Empagliflozin is also approved by FDA to lower heart attack and stroke risk in adults with type 2 diabetes and heart disease.

Necrotizing Fasciitis / Fournier’s Gangrene

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 — the space between the anus and scrotum in the male and between the anus and vulva in the female. The bacteria usually get into the body through a cut or break in the skin, where they quickly spread and destroy the tissue they infect.

Diabetes Drug Gangrene Lawsuit

The FDA web site states that “having diabetes is a risk factor for developing Fournier’s gangrene; however, this condition is still rare among diabetic patients. Overall published literature about the occurrence of Fournier’s gangrene for men and women is very limited. Publications report that Fournier’s gangrene occurs in 1.6 out of 100,000 males annually in the U.S., and most frequently occurs in males 50-79 years (3.3 out of 100,000).

From March 2013 to May 2018, the FDA says it found 12 cases of Fournier’s gangrene in patients taking an SGLT-2 inhibitor.  But that number includes only reports submitted to FDA and found in the medical literature.  The FDA admits there may be more cases about which it is not aware.

Disfiguring Surgeries, One Death from SGL2 Inhibitors

The FDA estimates that some 1.7 million patients received a dispensed prescription for an SGLT-2 inhibitor in 2017.  The agency said that the 12 Fournier’s gangrene cases it saw included 7 men and 5 women.  All developed Fournier’s gangrene several months after starting an SGLT2 inhibitor. All 12 were hospitalized and required surgery. Some suffered multiple disfiguring surgeries.  Some developed complications.  One patient died.  By contrast, the agency said that “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.

Invokana Amputation Warning

The FDA had previously warned that Invokana and other SGLT2 Inhibitor drugs can cause an increased risk of amputations.

Free Legal Consultation

Our law firm is pursuing cases involving injuries from Invokana and other SGLT2 Inhibitor drugs.  Contact us for a free legal consultation if you or someone you love suffered genital infection, Fournier’s gangrene, necrotizing fasciitis, or amputation after taking an SGL2 Inhibitor drug —  Invokana, Farxiga, Jardiance, or Steglatro.

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