Invokana, Jardiance Side Effects Caused Diabetic Ketoacidosis: Lawsuit

A recently filed product liability lawsuit indicates that side effects of Invokana and Jardiance, which are both member of a new class of diabetes drugs, caused a Utah woman to suffer severe health complications due to diabetic ketoacidosis. 

The complaint (PDF) was brought last week by Patricia MacMurray in the U.S. District Court for the Southern District of Indiana, naming Johnson & Johnson’s Janssen Pharmaceuticals subsidiary, as well as Eli Lilly and Boehringer Ingelheim Pharmaceuticals, Inc., as defendants.

MacMurray indicates that she began taking Invokana in early 2015, and then began taking Jardiance in March 2015. Shortly thereafter, MacMurray developed diabetic ketoacidosis, which involves a dangerous buildup of acid levels in the blood, which caused her to be hospitalized for seven, with treatment in the intensive care unit (ICU).

Invokana and Jardiance are both part of a new-generation of type-2 diabetes treatments introduced in recent years, known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. Although the medications have only been on the market for a few years, the drug makers have aggressively promoted the treatments as superior alternatives to older diabetes medications. Other members of the same class include Farxiga, Invokamet, Glyxambi and Xigduo XR.

Concerns about the potential link between Invokana, Jardiance and ketoacidosis emerged in May 2015, when the FDA indicated that during the first 15 months the new class of diabetes drugs was on the market, more than 20 adverse event reports were received involving individuals using an SGLT2 inhibitor who required emergency room treatment or hospitalization due to diabetic ketoacidosis, ketosis, acidosis or other related conditions.

Ketoacidosis can result in symptoms like difficulty breathing, nausea, vomiting, abdominal pain, confusion, fatigue or sleepiness, often requiring urgent medical treatment and potentially resulting in severe health consequences.

Although diabetic ketoacidosis is commonly associated with type 1 diabetes, it is not normally seen among individuals diagnosed with type 2 diabetes, which is the type of diabetes Jardiance and Invokana are approved to treat. Type 2 diabetes is an acquired and curable condition, while type 1 diabetes is usually something someone is born with and persists for life.

In addition to concerns about ketacidosis, a number of lawsuits over Invokana kidney problems have been filed against Janssen, alleging the drug maker also failed to adequately warn that the medication may increase the risk of kidney failure and other complications.

In May 2015, the Institute for Safe Medication Practices (ISMP) conducted a detailed review of adverse event reports submitted to the FDA during the first year Invokana was on the market, and identified a potential risk of kidney damage with Invokana and other SGLT2 inhibitors, raising questions about whether the benefits provided by the medication justify the risk.

In June 2016, the FDA released a new Invokana safety warning, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.

A number of lawyers are now reviewing potential Jardiance lawsuits and Invokana lawsuits for individuals hospitalized due to ketoacidosis and kidney damage. Plaintiffs claim that the drug makers placed their desire for profits before consumer safety, but withholding information about the risks associated with the new generation diabetes treatments.