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Invokana Label Updated With Ketoacidosis and UTI Warnings

Invokana Label Updated With Ketoacidosis and UTI Warnings

The FDA has update the label on Invokana to include warnings about too much acid in the bloodstream (ketoacidosis) and serious urinary tract infections.

In a Safety Communication issued on December 4, 2015, the FDA added new warnings for type-2 diabetes drugs in the sodium-glucose cotransporter-2 (SGLT2) class.

According to the FDA, patients on Invokana should stop taking it and seek medical attention immediately if they have any symptoms of ketoacidosis, a condition in which the body produces too much blood-acids called ketones.

Symptoms of diabetic ketoacidosis:

  • Nausea
  • Vomiting
  • Abdominal pain
  • Tiredness
  • Trouble breathing

The FDA warns that ketoacidosis associated with Invokana can occur even when blood-sugar levels are not very high. The agency previously warned about the risk in May 2015, after receiving 73 reports of ketoacidosis in patients on SGLT2 inhibitors since March 2013. According to the FDA:

“All patients required hospitalization or treatment in an emergency department. In many cases, ketoacidosis was not immediately recognized because the blood glucose levels were below those typically expected for diabetic ketoacidosis. As a result, treatment of the ketoacidosis was delayed in some cases.”

The FDA also said patients should be vigilant for symptoms of a urinary tract infection, such as a burning sensation when urinating, frequent urination, pain in the lower part of the stomach or pelvis, fever, and blood in the urine.

The agency identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that began as urinary tract infections between March 2013 and October 2014. All of the patients were hospitalized and some needed intensive care or dialysis due to kidney failure.

Do I have an Invokana Lawsuit?

The Schmidt Firm, PLLC is currently accepting Invokana 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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