Invokana Diabetic Ketoacidosis Problems Rare, Drug Maker’s Researchers Say

In response to recent FDA concerns about the potential side effects of Invokana, researchers for the maker of the new-generation diabetes drug indicate that their data suggest reports diabetic ketoacidosis are rare. 

A new study conducted by researchers working for Johnson & Johnson’s Janssen Pharmaceuticals subsidiary indicates that the rate of diabetic ketoacidosis problems among users of Invokana was similar to the rate seen among the general population of people with type 2 diabetes. The findings were published in the August issue of the medical journal Diabetes Care.

Janssen researchers looked at data on 17,596 patients who participated in randomized studies of Invokana (canagliflozin) and collected data on all serious adverse events of diabetic ketoacidosis (DKA), ketoacidosis, metabolic acidosis, and acidosis. Each of those conditions involve the accumulation of high levels of acid in the blood, which can lead to severe and potentially life-threatening health risks.

According to their study, there were 12 ketoacidosis events where patients were treated with Invokana, representing 0.07% of patients. Rates were slightly higher, 0.11%, when patients were given the higher dose of 300 mg. Researchers claim that the patients were likely also on insulin and had other factors that made diabetic ketoacidosis more likely.

“DKA and related events occurred at a low frequency in the canagliflozin type 2 diabetes program, with an incidence consistent with limited existing observational data in the general population with type 2 diabetes,” the researchers concluded.

Invokana Ketoacidosis Concerns

The study comes after the FDA announced in May that it was reviewing whether regulatory actions are necessary as a result of recent reports involving ketoacidosis problems with Invokana and other SGLT2 inhibitor diabetes drugs.

Invokana was approved by the FDA in March 2013, as the first in a new class of diabetes medications that work in a unique way by impacting the normal function of the kidney, causing an increased amount of sugar to be excreted in the urine.

Over the past two years, other new drugs have been approved in this same class, including Farxiga, Invokamet, Glyxambi, Jardiance, and Xigduo XR. However, Invokana was the first to market and is the most widely used of the new-generation of drugs.

Concerns about the potential link between Invokana and ketoacidosis emerged in May, when the FDA indicated that during the first 15 months Invokana was on the market, more than 20 adverse event reports were received involving individuals using an SGLT2 inhibitor who required emergency room treatment or hospitalization due to diabetic ketoacidosis, ketosis, acidosis or other related conditions.

Ketoacidosis occurs when high levels of blood acids, known as ketones, build up in the blood. This can result in symptoms like difficulty breathing, nausea, vomiting, abdominal pain, confusion, fatigue or sleepiness, often requiring urgent medical treatment and potentially resulting in severe health consequences.

Although diabetic ketoacidosis is commonly associated with type 1 diabetes, it is not normally seen among patients diagnosed with type 2 diabetes, which is the type of diabetes Invokana and the other drugs are approved to treat. Type 2 diabetes is an acquired and curable condition, while type 1 diabetes is usually something someone is born with and persists for life.

A growing number of lawyers are now reviewing potential Invokana lawsuits for individuals hospitalized due to ketoacidosis, considering claims for failure to adequately research the new diabetes drug or adequately warn about the potential side effects.