FDA Adds Warnings to Invokana Drug Label

FDA Adds Warnings to Invokana Drug Label

On December 4, 2015, the Food and Drug Administration (FDA) released a drug safety communication after a safety review resulted in adding warnings to the labels of a class of Type 2 diabetes drugs called sodium glucose cotransporter-2 inhibitors or SGLT2 inhibitors, like Johnson & Johnson’s Invokana.

The agency revised the labels to include risks of too much acid in the blood and serious urinary tract infections (UTIs). Both conditions may lead to hospitalization. SGLT2 inhibitors release blood sugar via the urine and reduce blood glucose levels. However, this increases the risk of diabetic ketoacidosis (DKA), a life-threatening condition in which the body produces high levels of blood acids called ketones.

DKA occurs when the body cannot break down sugar as an energy source. Instead, the body burns fat for energy, producing ketones. Ketones are waste products and poison the body. DKA can cause diabetic coma, even death. The FDA warns, “Patients should stop taking their SGLT2 inhibitors and seek medical attention immediately if they have any symptoms of ketoacidosis.” Symptoms include nausea, vomiting, trouble breathing, confusion, abdominal pain, and fatigue. DKA associated with the use of SGLT2 inhibitors can occur with normal blood glucose levels. Consequently, this may delay treatment of the ketoacidosis because the blood glucose levels were below those typically expected for diabetic ketoacidosis.

SGLT2 inhibitors, such as Invokana, may cause urinary tract infections or bladder infections. The signs and symptoms of a UTI include painful urination, burning sensation in the urethra, frequent urination or urge to urinate, blood in the urine, fever, and flank pain (pain in the lower stomach or pelvis). Symptoms in the elderly can be vague or non-specific.

Healthcare professionals should monitor patients taking SGLT2 inhibitors who present with suggestive symptoms for ketoacidosis and urinary tract infections.

If you suffered diabetic ketoacidosis (DKA) or a urinary tract infection (UTI) after taking Invokana, contact an attorney at Kershaw, Cook & Talley for a free case evaluation at (916) 520-6639.


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