FDA Adds Ketoacidosis and UTI Warnings to Invokana Label

The warning label for Invokana has been updated to include ketoacidosis (too much acid in the blood) and severe urinary tract infections that can lead to kidney failure.

On December 4, 2015, the FDA issued a Safety Communication for all medications in the sodium-glucose cotransporter-2 (SGLT2) class, including Invokana. SGLT2 inhibitors treat type-2 diabetes by preventing the kidneys from re-absorbing glucose (sugar) back into the bloodstream.

The problem is that patients on Invokana can develop life-threatening diabetic ketoacidosis, a condition in which toxic levels of blood-acids called ketones poison the body. Patients on Invokana can develop ketoacidosis even when their blood-sugar level is very high, which can delay diagnosis and increase the risk of severe side effects.

Between March 2013 and May 2015, the FDA received 73 reports of patients on SGLT2 inhibitors who were hospitalized with ketoacidosis. Many more cases were likely never reported, according to a previous Safety Communication issued in May 2015.

The FDA recommends that patients on Invokana should stop taking it and seek emergency medical attention if they develop symptoms of ketoacidosis, such as:

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

The FDA also warned about the risk of severe urinary tract infections. Symptoms may include a painful sensation when urinating, frequent and urgent urination, pelvic or lower-abdominal pain, fever, and blood in the urine.

Between March 2013 and October 2014, the FDA received 19 reports of patients on SGLT2 inhibitors who were hospitalized with life-threatening complications, including blood infections (urosepsis), kidney infections (pyelonephritis), and kidney failure.

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