Invokana Linked to Over 150 Reports of Metabolic Acidosis

January 27, 2016 — As the popularity of diabetes drugs like Invokana increases, the FDA had received substantially more reports of diabetic ketoacidosis (DKA) and serious infections.

The Institute for Safe Medication Practices (ISMP) QuarterWatch (PDF) report examined FDA MedWatch adverse event reports for several new diabetes drugs.

Over the last year, Invokana (canagliflozin) has been linked to 168 possible cases of metabolic acidosis. Another 80 cases were linked to Farxiga (dapagliflozin) and 12 cases with Jardiance (empagliflozin). During that time, the FDA has received nearly 5,500 adverse event reports for Invokana.

The most frequently-reported side effect was genital fungal infections, which is not surprising because glucose in urine creates favorable conditions for infections. In clinical trials, 11.4% of women on Invokana developed yeast infections.

In December 2015, the FDA warned about reports of urinary infections that became life-threatening after spreading to the kidneys and/or bloodstream. The agency also said it had received 73 reports of ketoacidosis between March 2013 and May 2015.

These diabetes drugs lower blood-sugar levels by causing the kidneys to excrete more glucose in urine rather than returning it to the bloodstream. Despite the lack of long-term safety data, 21% of adults in the United States with type-2 diabetes are currently taking one of these three drugs, according to the ISMP.

Metabolic acidosis is a condition in which the blood and other body fluids become too acidic. In people with diabetes, ketoacidosis occurs when acidic toxins called ketones accumulate when the body starts burning fat instead of using blood-sugar for energy. Left untreated, it can lead to diabetic coma (unconsciousness) and death.

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