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FDA Adds Ketoacidosis and UTI Risk to SGLT2 Inhibitor Labels

FDA Adds Ketoacidosis and UTI Risk to SGLT2 Inhibitor Labels

December 7, 2015 — The FDA has issued a Safety Communication and updated the labels on SGLT2 inhibitor diabetes drugs to warn about ketoacidosis and severe urinary tract infections.

The FDA previously warned about the risk of ketoacidosis in May 2015, after receiving SGLT2 inhibitors were linked to 73 reports of ketoacidosis since March 2013.

The FDA also warned about the risk of life-threatening complications from urinary tract infections after receiving 19 reports of patients who developed urosepsis (blood infections) and pyelonephritis (kidney infections). All of the patients were hospitalized and several required dialysis for kidney failure or treatment in the intensive care unit.

SGLT2 inhibitors are associated with cases of ketoacidosis that occur even when blood-sugar levels are not very high. The FDA recommends:

“Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones. Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.”

The sodium-glucose cotransporter 2 (SGLT2) inhibitor class of drugs includes canagliflozin (Invokana, Invokamet), dapagliflozin (Farxiga), and empagliflozin (Jardiance). These drugs help people with diabetes improve glycemic control by improving insulin sensitivity and increasing the amount of glucose absorbed by muscle cells.

Do I have a Diabetes Drug Lawsuit?

The Schmidt Firm, PLLC is currently accepting diabetes drug induced injury cases in all 50 states. If you or somebody you know has been diagnosed with ketoacidosis, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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