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Federal regulators issued yet another warning about the side effects of Invokana, Jardiance, Farxiga and similar diabetes drugs; this time indicating that they have been linked to serious genital infections.
The FDA issued a drug safety communication on Wednesday, indicating that drugs belonging to a class of medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors have been linked to cases of rare but serious infections around the genitals.
The infections, necrotizing fasciitis of the perineum, are also known as Fournier’s gangrene. It is commonly referred to as a “flesh-eating” infection. It is a rare infection that can be life threatening. The FDA noted that while diabetes can increase the risk of the infections, it is still rare among diabetic patients.
However, it is likely that the number of cases of Fournier’s gangrene linked to the drugs will increase as awareness of the connection becomes known.
“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 indicates. “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 indicate that the FDA only receives about 10% or less of drug adverse event incidents.
Even then, the FDA warning notes that this is twice as many cases than have been linked to all other diabetes drugs combined over the past three decades, but these occurred in just a five year span. Additionally, five of the cases linked to SGLT2 inhibitor use involved women, while all of the previous cases linked to other diabetes drugs involved men.
The FDA is requiring new label warnings be added to all drugs that belong to the class, including Invokana, Invokamet, Invokamet XR, Farxiga, Xigduo XR, Qtern, Jardiance, Glyxambi, Synjardy, Synjardy XR, Steglatro, Segluromet and Steglujan. Steglatro is the only drug that has not been linked to a case of flesh-eating genital infection, but the agency is requiring it to carry a label warning anyway.
The agency indicates that the infections developed within several months of beginning treatment with one of the drugs and all 12 patients underwent hospitalization and surgery. According to the FDA’s findings, at least one patient died, while others suffered multiple disfiguring surgeries and other complications.
Other Health Concerns Linked To Invokana and Similar Drugs
The flesh-eating genital infection warning is just the latest adverse health risk added to Invokana and similar drugs since they were first introduced on the market. The previous warnings have included kidney failure, diabetic ketoacidosis and amputations (specifically for Invokana). The drugs did not carry warnings for any of those risks when they were first approved by the FDA.
Invokana (canagliflozin) was the first SGLT-2 inhibitor introduced to the market, which was approved in March 2013 and quickly became a blockbuster treatment. The medication works in a unique way, impacting some normal kidney functions to help remove glucose from the body through urine.
In December 2015, the FDA required Johnson & Johnson to add new diabetic ketoacidosis warnings to Invokana and similar drugs, indicating that the medications increase the risk of this serious condition, which typically results in the need for emergency treatment to avoid life-threatening injury. Prior to the update, the warnings failed to alert consumers about the importance of seeking immediate medical attention if they experience symptoms like abdominal pain, fatigue, nausea, respiratory problems or vomiting.
In June 2016, the FDA required additional label warnings about the link between kidney risks and Invokana and other drugs from its class, indicating that the medications may increase the risk of acute kidney injury and other severe health problems.
n May 2017, FDA required new warnings about the Invokana amputation risks, adding information to the drug label about the increased incidence of leg, foot and toe amputations. That warning was only required for Invokana, and manufacturers of other SGLT-2 inhibitors have suggested that Invokana leg and foot amputation problems were unique to that drug, maintaining that the same risks were not seen among users of their medications.
Johnson & Johnson and Janssen face several thousand Invokana lawsuits, which allege that users and the medical community were not provided adequate warnings at the time the drug was first introduced. The makers of other diabetes drugs from the same class, including Farxiga and Xigduo XR, have also faced similar lawsuits; though most have been filed against the makers of Invokana.
The FDA indicates that there were 1.7 million prescriptions dispensed for SGLT2 inhibitors in 2017. The agency requests anyone who has suffered side effects after taking one of these drugs file a report with the FDA MedWatch adverse event reporting system.
Tags: Amputation, Diabetes, Diabetes Drug, Farxiga, Glyxambi, Infection, Invokamet, Invokamet XR, Invokana, Jardiance, Johnson & Johnson, Kidney Failure, Qtern, Segluromet, Steglatro, Steglujan, Synjardy, Synjardy XR, Xigduo XR