FDA Warnings for Invokana Users

This new SGLT2 inhibitor warning comes on the heels of a drug safety communication issued by the FDA in May 2015, which included information about the potential for the Type 2 diabetes drugs to cause diabetic ketoacidosis, a condition characterized by too much acid in the blood. A growing body of research has linked the use of Invokana and other popular SGLT2 inhibitors to an increased risk of diabetic ketoacidosis (DKA), which is characterized by symptoms like nausea, vomiting, tiredness, abdominal pain and difficulty breathing. Diabetic ketoacidosis is a medical emergency, and without treatment, the condition may result in diabetic coma and death.

As the FDA’s December 2015 warning states, “A review of the FDA Adverse Event Reporting System database from March 2013 to May 2015 identified 73 cases of ketoacidosis in patients with type 1 or type 2 diabetes treated with SGLT2 inhibitors.” The FDA also identified “19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections with the SGLT2 inhibitors reported […] from March 2013 through October 2014. All 19 patients were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat kidney failure.”

Alleged Side Effects of SGLT2 Inhibitors

In light of these potential complications, the FDA has added new Warnings and Precautions to the labels of all SGLT2 inhibitor drugs, including Invokana (canagliflozin), Farxiga (dapagliflozin), Invokamet (canagliflozin/metformin), Glyxambi (empagliflozin/linagliptin), Xigduo XR (dapagliflozin/metformin) and Jardiance (empagliflozin), describing the risk of serious urinary tract infections and ketoacidosis side effects in users. The agency is also requiring the makers of SGLT2 inhibitors to conduct post-marketing research to analyze reports of diabetic ketoacidosis complications in patients treated with SGLT2 inhibitors, including specialized follow-up for a period of five years.

SGLT2 inhibitors like Invokana are Type 2 diabetes medications designed to work by causing glucose to be excreted in the urine, thereby lowering glucose levels in the bloodstream. However, the medications have been linked to an increased risk of diabetic ketoacidosis, kidney failure, heart attack, cardiovascular problems, abnormal weight loss, allergic reactions, wrongful death, and now serious urinary tract infections as well. According to the FDA, the 19 cases of serious urinary tract infections only occurred in patients treated with Invokana or Farxiga, but the agency did not indicate that Jardiance and other SGLT2 inhibitors are free of such a risk.

Contact a Reputable Invokana Attorney Today

According to the FDA’s new Invokana side effect warning, “Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis,” and “Health care professionals should assess for ketoacidosis and urinary tract infections in patients taking SGLT2 inhibitors who present with suggestive symptoms.” If you took Invokana or another similar Type 2 diabetes drug, and you have since suffered diabetic ketoacidosis, a urinary tract infection, or another serious medical complication, contact a knowledgeable product liability lawyer today to explore your possible compensation options.