On November 13, 2015, a Texas woman filed a new Invokana lawsuit against manufacturers Janssen Pharmaceuticals and parent company Johnson & Johnson (J&J). She blames the defendants for the serious injuries she suffered after taking the type 2 diabetes drug.
The case was filed in the U.S. District Court for the District of New Jersey. The plaintiff seeks in excess of $10 million in both compensatory and punitive damages.
Plaintiff Claims Invokana Caused DKA and Kidney Damage
According to her complaint, the plaintiff started taking Invokana in October 2013 for the treatment of her type 2 diabetes. Invokana (canagliflozin) belongs to a class of medications known as “sodium-glucose co-transporter 2 (SGLT-2) inhibitors.” These drugs lower blood glucose levels by preventing the kidneys from reabsorbing some glucose. As a result, some is flushed out of the body via the urine.
The plaintiff says that she used the medication as directed, and that she relied on materials created by the defendants, which indicated that the drug was safe and effective. Within just a short time of starting the prescription, however, she suffered from serious injuries, and stopped taking it in November 2013.
As a direct result of her ingestion of Invokana, the plaintiff states that she suffered from diabetic ketoacidosis (DKA) and severe kidney damage.
Invokana Linked with Risk of DKA
The FDA approved Invokana for the treatment of type 2 diabetes in March 2013. Two years later, they released a safety communication warning patients and doctors that the drug had been linked with over 20 cases of DKA, for which the patients had to be hospitalized.
DKA is a condition in which the blood becomes too acidic. Without immediate treatment, it can cause long-term health problems, including coma and even death. The FDA noted in their safety communication that they were concerned about reports of patients with type 2 diabetes taking drugs like Invokana suffering from DKA.
“Patients should pay close attention for any signs of ketoacidosis,” they stated, “and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, or unusual fatigue or sleepiness.”
The plaintiff in this case states that the defendants should have known about this risk and should have included warnings on their label alerting doctors and patients to the danger, but the defendants failed to place such a warning on the drug label. She says had she been aware of the risk, she would not have used Invokana.
Invokana Also Linked with Kidney Damage
Invokana has also been linked with the plaintiff’s other injury: kidney damage.
In the ISMP QuarterWatch report for 2014, Invokana was linked with 457 reports of health issues, including kidney stones, kidney impairment and kidney failure. The authors questioned the safety of the drug, writing: “Also, early signals for a new kind of diabetes drug, canagliflozin (INVOKANA) raise questions about whether enough is known about this agent to be assured that its benefits outweigh its risks.”
There are some questions about how Invokana works. For example, because it inhibits the kidneys from reabsorbing glucose, forcing them to process glucose in a different way, might that increase the risk of infections and kidney problems?
Early animal studies on the drug seemed to show an increased risk for side effects like kidney damage, and even those experts who first reviewed clinical trials on the drug for the FDA’s approval process expressed concern, stating that Invokana’s potential long-term effect on the kidneys was unknown.