By Emily Cox
The FDA has issued yet another warning regarding horrific side effects from Invokana, Jardiance, Farxiga, and other similar diabetes drugs. This time, the agency indicates the drugs are linked to serious genital infections.
Federal regulators released the latest Invokana drug safety communication Wednesday in a long series of similarly significant warnings regarding sodium-glucose cotransporter-2 (SGLT2) inhibitors. This time around, the FDA says that the drugs have now been linked to cases of rare but serious flesh-eating genital infections.
SGLT2 Genital Infections
Necrotizing fasciitis of the perineum, also known as Fournier’s gangrene, is commonly classified as a “flesh-eating” infection. Federal regulators indicate that the rare infection can be life threatening. Diabetes alone can increase the risk of these infections. It is still rare among diabetes patients but cases involving SGLT2 inhibitors are currently on the rise. The FDA anticipates that the number of genital infections linked to the medications will likely increase significantly as awareness regarding the connection continues to spread.
“In the five years from March 2013 to May 2018, we identified 12 cases of Fournier’s gangrene in patients taking an SGLT2 inhibitor,” the warning notes. “This number includes only reports submitted to FDA and found in the medical literature, so there may be additional cases about which we are unaware.”
Most drug experts agree that the FDA only receives notice of approximately 10 percent or less of drug adverse event incidents.
Even within this limited scope, federal regulators note that their findings indicate that there are twice as many cases of genital infections with SGLT2 inhibitors as those linked to all other diabetes drugs combined over the past three decades. The SGLT2 genital infections also only occurred in a mere five-year span. Furthermore, five of the SGLT2 inhibitor cases involved women. All previous cases associated with other diabetes drugs only involved men.
Consequently, the FDA is mandating new warning labels for all drugs in the class. This includes Invokana, Invokamet, Invokamet XR, Farxiga, Xigduo XR, Qtern, Jardiance, Glyxambi, Synjardy, Synjardy XR, Steglatro, Segluromet, and Steglujan. Steglatro is the only drug that appears to be free of flesh-eating genital infection associations. However, the agency is requiring it to carry the label regardless.
Regulators indicate that the infections developed within several months of starting treatment with one of these drugs. All 12 patients underwent hospitalization and surgery. According to their findings, at least one patient died. Others have suffered numerous disfiguring surgeries and other irreparable complications.
SGLT2 Health Concerns Beyond Genital Infections
Flesh-eating genital infections are just the latest in a string of significant health risks from SGLT2 inhibitors like Invokana that the FDA has uncovered since manufacturers first introduced them to the market. Previous warnings include kidney failure, diabetic ketoacidosis, and amputations. However, manufacturers continue to maintain that amputation risks are unique to Invokana specifically. The drugs’ warning labels failed to address any of these substantial risks when they first received FDA approval.
Invokana (canagliflozin) was the first SGLT2 inhibitor to hit the market. The FDA approved the drug in March 2013. Thanks to Johnson & Johnson’s typically aggressive marketing approach, the medication soon became a blockbuster treatment and has remained at the front of the pack ever since. SGLT2 inhibitors work in a unique way by eliminating excess glucose from the body through urination by impacting some normal kidney functions.
In December 2015, the FDA required all SGLT2 inhibitors to carry warnings about diabetic ketoacidosis, indicating that the medications significantly increase the risk for this serious condition that generally requires emergency treatment to avoid life-threatening injuries. Prior to the FDA’s intervention, warnings failed to alert patients of the importance of seeking immediate medical help if they experienced abdominal pain, nausea, fatigue, vomiting, or respiratory problems.
In June 2016, the FDA mandated additional warning labels about the connection between kidney risks and SGLT2 inhibitors, telling patients that the medications can increase the risk of acute kidney injury, kidney failure, and other severe health issues.
In May 2017, the FDA intervened once again to require amputation risks for Invokana, indicating the drug carries an increased incidence of leg, foot, and toe amputations. Regulators are only requiring Invokana to carry these warning labels for now.
Currently, Johnson & Johnson and its Janssen Pharmaceutical subsidiary are facing several thousand Invokana lawsuits, alleging that the healthcare behemoths deliberately withheld significant risk factors when they introduced the drug to maximize its marketability. Manufacturers of other diabetes drugs in the same class, including Xigduo and Farxiga, are also facing similar lawsuits. But, most of the lawsuits pending in the nation’s court systems are against J&J and Janssen thanks to the companies’ reckless, but supremely effective, marketing tactics.
The FDA indicates that prescribers wrote 1.7 million prescriptions for SGLT2 inhibitors in 2017. The agency is urging anyone who has suffered side effects after taking one of these medications to file a report with the FDA MedWatch adverse event reporting system.