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According to allegations raised in a product liability lawsuit filed this week by a Tennessee man, Johnson & Johnson and it’s Janssen Pharmaceuticals subsidiary failed to adequately warn about the potential kidney risks associated with side effects of Invokana.
The complaint (PDF) was filed by Wardell Fleming in the U.S. District Court for the Western District of Tennessee on December 14, indicating that the new-generation diabetes drug caused him to suffer kidney failure, kidney damage and reduced kidney function.
Fleming indicates that he was prescribed Invokana in November 2013, for treatment of his diabetes and to reduce his blood sugar. However, he alleges that he developed serious kidney problems from Invokana, and also states that he is now at an increased risk of heart attack, stroke, and diabetic ketoacidosis due to the side effects of the drug.
Invokana (canagliflozin) is a new-generation diabetes treatment first introduced in March 2013, for treatment of type 2 diabetes. It was the first member of a new class of drugs, known as sodium-glucose co-transporter 2 (SGLT2) inhibitor, 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, several critics have suggested this may cause users to face an increased risk of severe kidney damage and kidney failure.
“SGLT2 inhibitors, including Invokana, are designed to inhibit renal glucose reabsorption with the goal of lowering blood glucose,” the lawsuit filed by Fleming explains. “As a result, excess glucose is not metabolized, but instead is excreted through the kidneys of a population of consumers already at risk for kidney disease.”
The case joins a growing number of Invokana lawsuits filed in recent weeks by individuals who indicate that the drug makers withheld information from consumers and the medical community about the risks associated with use of the new diabetes treatment.
Invokana Kidney Problems
Allegations raised in the complaints mirror concerns raised by the Institute for Safe Medication Practices (ISMP) in May 2015, in an independent report that evaluated adverse event reports submitted to the FDA involving Invokana problems the first year the drug was on the marketing. The report identified potential safety signals involving kidney damage that may be linked to the way Invokana and other SGLT2 inhibitors work.
The group raised questions about whether the potential risks associated with the medication may outweigh the benefits, leading some questions to be raised about whether an Invokana recall should be issued, or limitations should be placed on who receives the medication.
During the first year Invokana was on the market, ISMP highlighted 457 serious adverse event reports submitted to the FDA involving complications from Invokana. These adverse event reports typically only account for a small portion of the total problems associated with prescription medications on the market.
Many of the reported Invokana kidney problems involved kidney failure, kidney impairment or problems with kidney stones, urinary tract infections, dehydration, hypersensitivity and abnormal weight loss. Looking at reports to the FDA’s adverse event reporting system, the ISMP found that Invokana received more serious adverse event reports than 92% of the other drugs regularly monitored by the group.
Fleming and other plaintiffs now pursuing lawsuits over kidney failure after Invokana use, allege that inadequate warnings about the potential risks were provided for users or the medical community.
“Defendants knew or should have known the risks associated with use of Invokana, including the risk of developing severe kidney injuries,” according to Fleming’s lawsuit. “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.”
Earlier this month, the FDA announced that new Invokana warnings will be required about the risk of diabetic ketoacidosis, as well as urinary tract infection, which may lead to kidney infections and potentially to the development of kidney failure.
The new warnings will also be added to other recently introduced SGLT2 inhibitors, including Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi.
Users are now being urged to seek immediate attention if they show signs of diabetic ketoacidosis on Invokana, which involves a dangerous build up of acid in the blood. The condition typically causes symptoms like difficulty breathing, nausea, vomiting, abdominal pain, confusion, fatigue or sleepiness, often resulting in the need for hospital treatment.
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.