In the wake of recent FDA warnings about the risk of flesh-eating infections from Invokana and similar diabetes drugs, a man is coming forward to take manufacturers to task for an Invokamet genital infection that ended in partial scrotum amputation.

Lee Letourneau filed the complaint in the District of New Jersey earlier this month. He developed Fournier’s gangrene after starting treating with Invokamet. The medication combines Invokana with the older diabetes drug metformin.

Letourneau began treatment with Invokamet in February 2017 and continued taking the diabetes medication throughout the rest of the year. After beginning treatment with the drug, he developed a life-threatening genital infection. Ultimately, the infection became so severe that it necessitated the removal of approximately 60 percent of his scrotum.

The Invokamet lawsuit indicates that Johnson & Johnson and its Janssen Pharmaceuticals unit deliberately withheld essential information pertaining to drug’s significant risks of developing Fournier’s gangrene and other serious infections. Consequently, Letourneau was completely unaware that the medication caused his infection until federal regulators issued a drug safety communication this past month.

FDA Invokamet Genital Infection Warning

The FDA issued a drug safety communication August 29, warning that Invokana, Invokamet, and other similar diabetes drugs were connected to reports of rare, but serious, genital infections. Fournier’s gangrene, also referred to as necrotizing fasciitis of the perineum, can be fatal and eat through flesh. Federal regulates indicated that, while diabetes can increase infection risks, the problems are still uncommon among diabetic patients not taking Invokana and similar medications.

According to the lawsuit, it is likely that the number of Invokana and Invokamet genital infections will continue to increase as awareness of the connection continues to spread.

“Defendants’ label for Invokamet does not contain a warning for Fournier’s gangrene. The label states only that gangrene may be a complication associated with lower limb amputations,” the lawsuit states. “It also states that animal studies were not conducted for Invokamet, but that in animal studies of canagliflozin and metformin individually, there were incidents of testicular tumors. Nowhere does the label state that a male patient might suffer Fournier’s gangrene, or lose part of his scrotum.”

Due to significant safety concerns, the FDA is now requiring new warnings to be included to all drugs that belong to the diabetes drug class. This includes Invokana, Invokamet, Invokamet XR, Xigduo XR, Farxiga, Jardiance, Qtern, Glyxambi, Segluromet, Steglatro, Synjardy, Synjardy XR, and Steglujan. While Steglatro is the only drug with no reports of flesh-eating genital infections, the agency is still requiring it to carry a warning label as a precaution.

The FDA indicates that the infections developed within months of starting treatment with one of the drugs. All 12 patients underwent hospitalization and surgery as a result of the severity of their infections. According to regulators, at least one patient died, and others suffered numerous disfiguring surgeries and other serious complications.

The flesh-eating genital infection alert is only the latest significant adverse health risk added to the diabetes drug class since they first emerged on the market. Previous warnings include kidney failure, diabetic ketoacidosis, and amputations.

Other Invokana and Invokamet Health Concerns

Invokana (canagliflozin) was the first SGLT2 inhibitor to hit the market. The drug received FDA approval in March 2013 and quickly became a blockbuster treatment. SGLT2 inhibitors work in a unique to eliminate excess glucose from the body through urination by impacting some normal kidney functions.

In December 2015, the FDA mandated new diabetic ketoacidosis warnings for Invokana and other drugs in its class. The agency indicated that the medications increase the risk of this serious condition which usually requires emergency treatment to avoid life-threatening injuries. Prior to the label update, the warnings failed to note the importance of seeking immediate medical attention for symptoms such as nausea, fatigue, respiratory problems, abdominal pain, or vomiting.

In June 2016, federal regulators required additional warnings about the association between kidney risks and the drug class, indicating that these medications can increase the risk of acute kidney injury and other significant health problems.

In May 2017, the FDA mandated further warning updates regarding Invokana amputation risks, indicating that the drug carries an increase risk for leg, foot, and toe amputations. Regulators are only requiring Invokana to carry these warnings. Manufacturers of other SGLT-2 inhibitors maintain that leg and foot amputation risks are unique to Invokana, indicating that these same risks have not emerged among users of their medications.

J&J and Janssen currently face several thousand Invokana lawsuits, alleging that they concealed the drug’s dangers from patients and the medical community. While most SGLT-2 inhibitor lawsuits are against Invokana manufacturers, there are similar lawsuits pending against other drugs in the class.

According to the FDA, 1.7 million prescriptions for SGLT2 inhibitors were dispensed in 2017 alone. The agency requests that anyone who suffers side effects after taking one of these drugs to filed a report with the FDA MedWatch adverse event reporting system.