A Texas woman has filed a $10 million Invokana lawsuit for diabetic ketoacidosis (DKA) and kidney damage allegedly related to her use of the Type 2 diabetes medication.
According to the complaint, which is currently pending in the U.S. District Court, District of New Jersey, the plaintiff began using Invokana in October 2013. However, she stopped taking the medication in November 2013, after being diagnosed with DKA and kidney damage. The plaintiff claims that Johnson & Johnson and its Janssen subsidiary are responsible for her injuries, as she relied on materials provided by the defendants that represented Invokana as a safe and effective medication.
Invokana was launched in 2013, and was the first sodium-glucose co-transporter 2 (SGLT-2) inhibitor approved by the U.S. Food & Drug Administration (FDA) to treat Type 2 diabetes. Just two years after Invokana was approved, the FDA announced that it was investigating 20 cases of DKA in patients who had taken SGLT2 inhibitors. This past December, the agency disclosed that new information regarding a possible link with ketoacidosis would be added to the labels of Invokana and other SGLT2 inhibitors. The FDA also revealed that at least 73 reports involving DKAn and SGLT2 inhibitors had been logged with its adverse event database from March 2013 to May 2015.
DKA, or ketoacidosis, is a dangerous condition in which toxic acids called ketones accumulate in the blood. Symptoms may include: nausea, vomiting, abdominal pain, tiredness, and trouble breathing.
In 2014, the Institute for Safe Medication Practices (ISMP) reported that Invokana had been linked to 457 adverse event reports, including kidney stones, kidney impairment and kidney failure.
In December, the FDA also warned that SGLT2 inhibitors had been associated with 19 reports of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that originated s urinary tract infections. The incidents were logged from March 2013 through October 2014. All of the cases resulted in hospitalization, and a few patients required admission to an intensive care unit or dialysis in order to treat kidney failure.