Thanks to the recent introduction of new diabetes drugs like Invokana, patients with type 2 diabetes have many more medication options now than they did a few years ago. But as is usually the case with new drugs, the long-term effects may take some time to be discovered.

Recent FDA warnings about possible Invokana side effectscan help patients better inform themselves about the drug’s associated risks.

Invokana is a brand name for the generic drug canagliflozin. The same drug is used in the brand-name medication Invokamet, which combines it with metformin.

Invokana is one of a relatively new group of drugs called SGLT2 inhibitors. These drugs lower abnormally high levels of blood sugar by stimulating the kidneys to remove sugar from the blood and transfer it to the urine.

Invokana Side Effects

Recent FDA action has addressed the risk of developing ketoacidosis and kidney failure, two less common but particularly dangerous Invokana side effects.

In a communication issued in May 2015, the FDA warned that drugs in the same class as Invokana may lead to ketoacidosis, a potentially deadly condition in which the blood becomes too acidic.

Ketoacidosis happens when cells process fat instead of sugar to get energy. Ketones are a by-product of that process. These acidic compounds can build up in the blood, causing a dangerous increase in blood acidity.

The FDA said a review of its adverse event reporting database revealed 20 cases of ketoacidosis reported in conjunction with SGLT2 inhibitor treatment, reported between March 2013 and June 2014.

All the patients in these reports required emergency room treatment, and some required admission to the hospital. New reports of ketoacidosis associated with SGLT2 inhibitors have continued to roll in since June 2014, the agency notes.

Ketoacidosis is traditionally considered a complication of type 1 diabetes. That’s why the episodes that have been reported in conjunction with Invokana use have been unusual, since they necessarily involve patients with type 2 diabetes.

The same patients also showed lower blood sugar levels than those that usually appear with diabetic ketoacidosis.

According to the warning label for Invokana, these lower levels of blood sugar caused some cases of ketoacidosis to be misdiagnosed initially, causing a delay in urgently needed treatment.

In addition to ketoacidosis, other Invokana side effects have reportedly led to renal impairment that in a few cases led to kidney failure.

The warning label for Invokana notes that the drug increases serum creatinine and decreases eGFR, two naturally occurring substances whose levels can indicate kidney problems.

The label recommends more frequent monitoring of renal function for Invokana patients whose eGFR is below a certain level.

Another FDA drug safety communication from December 2015 addressed the issue of kidney problems associated with SGLT2 inhibitors like Invokana.

The agency said it had identified 19 cases of life-threatening blood and kidney infections that required hospitalization.

All these cases had started as urinary tract infections in patients taking SGLT2 inhibitors. Patients in a few cases developed kidney failure requiring dialysis or admission to intensive care.