Invokana Side Effects Caused Diabetic Ketoacidosis, Severe Kidney Injury, Lawsuit Claims

According to allegations in a recent product liability lawsuit filed against Johnson & Johnson’s Janssen Pharmaceuticals subsidiary, side effects of Invokana caused a Louisiana man to experience ketoacidosis and severe kidney damage within months of being switched to the new generation diabetes treatment. 

The complaint (PDF) was filed by Charles Maddox on February 10, in the U.S. District Court for the Eastern District of Louisiana, alleging that the drug maker has concealed their knowledge of Invokana’s “unreasonably dangerous risks” from consumers and the medical community.

Maddox indicates that he began taking Invokana in July 2014, barely one year after the new treatment was introduced for treatment of type 2 diabetes. He continued to use the medication until February 2015, but indicates that he soon developed severe kidney damage and suffered diabetic ketoacidosis (DKA), which is a serious and potentially life-threatening condition involving the build up of acid within the blood.

Invokana (canagliflozin) was first introduced in March 2013, as the first member of a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work in a unique way by impacting some of the normal kidney functions to increase the amount of sugar excreted in the urine. However, serious concerns have emerged about the safety of Invokana amid reports that suggest it may increase the risk of diabetic ketoacidosis (DKA), severe kidney damage and kidney failure.

Diabetic ketoacidosis (DKA) is a medical emergency that results in the need for immediate medical treatment and may lead to long-term health complications if not promptly treated. Symptoms of DKA may include abdominal pain, nausea, vomiting, fatigue, shortness of breath or other complications.

“The development of Plaintiff’s injuries was preventable and resulted directly from Defendants’ failure and refusal to conduct proper safety studies, failure to properly assess and publicize alarming safety signals, suppression of information revealing serious and life-threatening risks, willful and wanton failure to provide adequate instructions, and willful misrepresentations concerning the nature and safety of Invokana,” the lawsuit filed by Maddox states. “This conduct and the product defects complained of herein were substantial factors in bringing about and exacerbating Plaintiff’s injuries.”

The case joins a growing number of Invokana lawsuits filed in recent weeks by individuals who suffered similar problems after switching to the new diabetes treatment, indicating that inadequate warnings were provided about the risk of ketoacidosis or kidney failure.

In December, the FDA announced that it is requiring new Invokana warnings about ketoacidosis, indicating that users should stop taking the drug and seek immediate medical attention if they develop symptoms. The new warnings also indicate that Invokana may cause urinary tract infections, kidney infections or blood infections, which could potentially lead to kidney infections and potentially to the development of kidney failure.

Similar warnings will also be added to other SGLT2 inhibitors introduced in recent years, including Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi.

While ketoacidosis is commonly seen among type 1 diabetics, it is not often diagnosed among individuals with type 2 diabetes, which Invokana is designed to treat.

Maddox’s lawsuit presents charges against the defendants of designing and manufacturing a defective drug, failure to warn, breach of warranty, redhibition, negligence, fraudulent misrepresentation, negligent misrepresentation, negligent design, fraudulent concealment, and fraud. It seeks both compensatory and punitive damages.