Invokana Lawsuit for Type 2 Diabetes Patients

What is Invokana?

Prescription drug prescribed to help with glycemic control in adults with Type 2 diabetes.

Invokana (canagliflozin) belongs to a class of Type 2 diabetes medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which are designed to be used in combination with diet and exercise to lower blood glucose levels in adults with Type 2 diabetes. The prescription medication, approved by the U.S. Food and Drug Administration (FDA) in March 2013, is currently manufactured by Johnson & Johnson’s Janssen Pharmaceuticals unit, and it functions by working with the kidneys to help excrete glucose through the process of urination. Although Invokana has only been on the market in the United States for a short time, the diabetes drug has already been linked to a potential risk of devastating side effects, including lower-extremity amputations and diabetic ketoacidosis (DKA).

Alleged Side Effects Leading to an Invokana Lawsuit

Since it first entered the market, Invokana has been aggressively marketed by Johnson & Johnson and Janssen Pharmceuticals as a safe and effective treatment for Type 2 diabetes. However, recent reports have suggested that diabetes patients taking SGLT2 inhibitors like Invokana may face an increased risk of lower limb amputations and other serious complications that could potentially lead to long-lasting medical problems, or possibly even death. Among the side effects allegedly linked to Invokana and other SGLT2 medications, like Invokamet (canagliflozin/metformin), Farxiga (dapagliflozin), Xigduo XR (dapagliflozin/metformin), Glyxambi (empagliflozin/linagliptin) and Jardiance (empagliflozin), are:

• Amputations
• Kidney failure
• Heart attack
• Diabetic coma
• Stroke
• Diabetic ketoacidosis
• Wrongful death
• Breathing difficulty
• Vomiting
• Abdominal pain
• Confusion
• Frequent urination
• Elevated levels ketones in urine
• Excessive thirst
• Unusual fatigue or sleepiness

Link Between Invokana and Lower-Extremity Amputations

According to researchers, the risk of amputations of the toes, feet and legs occurred twice as often in study participants taking Invokana than in those taking a placebo, though the reason why this risk exists remains unknown. The most common levels of amputation associated with Invokana treatment are the toe and mid-foot (occurring in 99 out of 140 patients with amputations receiving Invokana in the CANVAS and CANVAS-R trials), but there have also been amputations involving the leg, below and above the knee, reported in connection with the diabetes drug (occurring in 41 out of 140 patients with amputations receiving Invokana in the two trials), as well as hand amputations and multiple limb amputations. Three Invokana users with amputations died.

Due to the estimated two-times increased risk of lower limb amputations associated with Invokana use, the FDA warns that if you take the drug for Type 2 diabetes, you should notify your healthcare provider immediately if you “develop new pain or tenderness, sores or ulcers, or infections in your legs or feet.” The FDA also advises healthcare providers to consider certain factors before putting a patient on Invokana, including any history of prior amputations, neuropathy, peripheral vascular disease or diabetic foot ulcers, which may predispose patients to the need for amputations. According to the FDA, lower limb infections, diabetic foot ulcers, gangrene, and ischemia were the most common precipitating medical events leading to an amputation among Invokana patients.

Link Between Invokana and Diabetic Ketoacidosis

Diabetic ketoacidosis, a subset of ketoacidosis or ketosis in diabetes patients, is a serious medical condition that occurs when the body produces high levels of ketones, or toxic acids in the bloodstream, which can lead to diabetic coma and death. According to reports, DKA typically develops in patients with Type 1 diabetes who also have high blood sugar levels. However, instances of diabetic ketoacidosis have been reported in patients with Type 2 diabetes who have only slightly increased blood sugar levels, when compared to typical cases of DKA, and this phenomenon is believed to be linked to the use of SGLT2 inhibitors like Invokana.

The first indication that Invokana treatment could put users at risk for ketoacidosis came in May 2015, following a search of the FDA’s Adverse Event Reporting System, which identified 20 instances of acidosis reported as diabetic ketoacidosis, ketoacidosis or ketosis in diabetes patients taking SGLT2 inhibitors like Invokana between March 2013 and June 6, 2014. According to the adverse event reports, all 20 cases included an emergency room visit or hospitalization in order for the patient to receive treatment for the ketoacidosis, and the FDA has indicated that the agency continues to receive reports of DKA side effects in Invokana patients.

The same month that the FDA issued its Invokana warning, the Institute for Safe Medication Practices (ISMP) released its own independent report based on adverse events submitted to the FDA, in which it highlighted the risk of kidney toxicity from the SGLT2 inhibitor. During the first year Invokana was on the market, the ISMP identified 457 serious adverse events reported to the FDA involving side effects of Invokana, and since these reports typically only account for a small percentage of the problem as a whole, it is likely that the risk of diabetic ketoacidosis, kidney failure and heart attack associated with Invokana treatment is significantly higher than originally believed.

Lawsuits Against Invokana for Amputations, Diabetic Ketoacidosis and Other Injuries

Though no Invokana lawsuits have made it to trial yet, hundreds of claims involving injuries allegedly caused by the diabetes drug have been consolidated in New Jersey for coordinated pretrial proceedings, as part of a multidistrict litigation (MDL). These cases will serve as bellwether trials for future lawsuits, and depending on the outcome of these trials, could convince Janssen to settle future claims out of court. As more information comes to light about the alleged risk of lower limb amputations, diabetic ketoacidosis and other devastating side effects from Invokana, additional product liability lawsuits are expected to be brought against Johnson & Johnson and Janssen Pharmaceuticals, on behalf of consumers who believe they have been harmed by the Type 2 diabetes drug. Though it’s impossible to say how much these Invokana claims could be worth, it should be noted that Japanese drug company Takeda was involved in a similar dispute over its Type 2 diabetes drug Actos, which had been linked to serious health problems in users, and ending up settling the lawsuits for $2.4 billion in 2015.