The US Food and Drug Administration has strengthened its warnings regarding Invokana (generically canagliflozin) and kidney side effects.

Invokana from Johnson & Johnson is used to maintain lower blood sugar levels in adults with type 2 diabetes. It works by making the kidneys remove sugar from the body through the urine rather than have it be reabsorbed into the blood.

As a result of this action, patients can become dehydrated, which taxes the kidneys.

From March 2013 through October 2015, there were 101 reports of acute kidney injury. Some of these patients required hospitalization or dialysis.

In about half of those cases, the patients had been on Invokana for a month or less, and most improved after stopping the drug.

Invokana Side Effects

Invokana side effects can be more pronounced in diabetics who take other medications such as NSAIDS (ibuprofen), diuretics and blood pressure drugs such as ACE inhibitors.

While Invokana can cause many side effects, acute kidney injury is one of the most serious and is the reason for the heightened warning by the FDA. In this kidney side effect, the kidneys suddenly stop working, causing dangerous levels of waste to build up in the patient’s system.

Symptoms of acute kidney injury can be decreased urine output and swelling of the legs or feet.

Invokana and Kidney Side Effects

Invokana redirects sugar away from the blood and into the urine, which in theory sounds like a great idea. However, the increased urine output can result in dehydration, which makes the kidneys vulnerable to damage. Invokana’s own warnings state “renal function abnormalities can occur after initiation.”

Invokana side effects also include an increased risk of ketoacidosis, which means the body has produced an abnormally high level of blood acids, and it can lead to brain swelling and kidney failure.

This occurs when the body’s cells don’t receive the glucose they need for energy, and the body begins to burn fat for energy, a process that produces ketones. These ketones break down the fat to turn it into energy.

When the ketones build up in the blood, the resulting ketoacidosis can make a person sick.

Symptoms of ketoacidosis are:

• Thirst or a very dry mouth
• Frequent urination
• High blood glucose (blood sugar) levels
• High levels of ketones in the urine

Symptoms of progressed ketoacidosis:

• Constantly feeling tired
• Dry or flushed skin
• Nausea, vomiting, or abdominal pain
• Difficulty breathing
• Fruity odor on breath
• A hard time paying attention, or confusion

Invokana Approved in 2013

The FDA approved Invokana in 2013 to help maintain blood sugar levels in type 2 diabetics. It was the first in a new class of medications called SGLT2 inhibitors that eliminate excess glucose (sugar) by sending it through the kidneys and out the urine instead of allowing the glucose back into the bloodstream.

In December 2015, the FDA ordered all manufacturers of SGLT2 inhibitors to include warning labels about the risk of ketoacidosis. At that time, the drugs were also made to add warnings regarding an increased risk of urinary tract infections as well.

Under normal conditions, ketoacidosis is rare in people with type 2 diabetes compared to those with type 1 diabetes. If you or a loved one has taken Invokana and suffered acute kidney injury or ketoacidosis you could be eligible for compensation.