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According to allegations raised in a kidney failure lawsuit filed over the side effects of Invokana, the new generation diabetes drug places additional stress on the kidneys for certain individuals.
The complaint (PDF) was filed by James W. Brown in the U.S. District Court for the Northern District of Alabama on November 7, indicating that Johnson & Johnson, its Janssen Pharmaceuticals subsidiary and Mitsubushi Tanabe Pharma Corp. failed to provide adequate warnings for users and the medical community about the serious kidney risks.
Invokana (canagliflozin) is a new type of diabetes drug introduced in early 2013, working in a unique way by inhibiting some normal kidney functions to increase the amount of sugar excreted in the urine. It was the first member of a new generation of medications, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors, which also includes the blockbuster drugs Invokamet, Faxiga, Jardiance and others.
Although the medications have been promoted as superior treatments to prior diabetes drugs, as more users have switched to Invokana or other SGLT2 inhibitors, serious questions about the safety and side effects of the medications have emerged.
Brown indicates that he began taking Invokana in October 2014, and suffered kidney failure in November 2014. As a result of the complications allegedly caused by Invokana, Brown claims that he required multiple days of hospitalization and has been left with permanent injuries and damages.
According to the lawsuit, Invokana place stress on the kidney, as the drug is designed to route excess glucose through the kidneys and out through the urine.
“SGLT2 inhibitors, including Invokana, inhibit renal glucose reabsorption through the SGLT2 receptor in the proximal renal tubules, causing glucose to be excreted through the urinary tract,” the lawsuit states. “This puts additional stress on the kidneys in patients already at risk for kidney disease.”
The complaint indicates that the drug makers knew or should have known about the Invokana risk of kidney failure and other problems associated with the medication, yet failed to warn patients, instead continuing to defend the safety of Invokana, mislead physicians and the public, and minimize unfavorable findings.
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 required the drug makers to add new Invokana safety warning, indicating that the medication may increase the risk of acute kidney injury and other severe health problems.
Brown’s case joins a growing number of similar Invokana lawsuits filed in courts nationwide. In addition to kidney failure cases, a number diabetic ketoacidosis lawsuits and heart attack lawsuits have been filed over other side effects associated with the medication.