Diabetic Ketoacidosis on Invokana May Result in Days of Hospitalization

Federal health regulators recently warned that side effects of Invokana and other similar diabetes drugs may be linked to a risk of diabetic ketoacidosis, resulting in dangerously high levels of acid in the blood. This often requires days of hospital treatment and may leave users of the diabetes drug with a long-lasting injury. 

In May, the FDA issued a drug safety communication to indicate that it is reviewing reports of ketoacidosis on Invokana and other new-generation diabetes drugs, known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. Other members of this class include Farxiga, Invokamet, Glyxambi, Jardiance, and Xigduo XR, but Invokana is the most widely used of the class.

The FDA indicated that least 20 reports were identified of individuals using one of these diabetes drugs who required emergency room treatment or hospitalization due to diabetic ketoacidosis, ketosis, acidosis or other related conditions during the first 15 months Invokana was on the market.

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.

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.

The FDA noted that all of the incidents of SGLT2 inhibitor ketoacidosis identified in the drug safety communication resulted in the need for hospital treatment, which is typical for the serious medical condition.

Treatment of diabetic ketoacidosis typically involves the replacement of fluids until the individual is rehydrated, as well as the replacement of electrolytes. It also often involves insulin treatments, which can reverse the process that leads to ketoacidosis. However, this must be done in a series of steps, with the insulin only introduced after fluids and electrolytes have been balanced.

It can take some time for the body’s chemistry to get back to normal. In October 2014, the U.S. Centers for Disease Control and Prevention (CDC) published a study indicating that the average length of stay in a hospital for ketoacidosis was 3.4 days as of 2009, the most recent year for which there was data. That is down from just under six days in 1988.

That study found that there were 140,000 hospitalizations in 2009 for DKA, and the problem costs the U.S. health system $2.4 billion annually.

Invokana Health Concerns

Invokana (canagliflozin) was approved by the FDA in March 2013, as the first in a new class of diabetes medications that work in a unique way. SGLT2 inhibitors impact the normal function of the kidney, causing an increased amount of sugar to be excreted in the urine. However, this new mechanism of action may be linked to safety concerns.

In addition to concerns about the link between Invokana and ketoacidosis, some reports suggest that the drug may also lead to kidney problems.

The same month as the FDA ketoacidosis warnings, the Institute of Safe Medication Practices (ISMP) released a report that also evaluated adverse events submitted to the FDA, identifying potential safety signals involving kidney toxicity and raising questions about whether the potential Invokana risks may actually outweigh the benefits provided by the diabetes drug.

During the first year Invokana was on the market, ISMP highlighted 457 serious adverse event reports submitted to the FDA involving complications with Invokana. These adverse event reports typically only account for a small portion of the total problems associated with prescription medications on the market.

Many of the reported Invokana problems involved kidney failure, kidney impairment or problems with kidney stones, urinary tract infections, dehydration, hypersensitivity and abnormal weight loss. Looking at reports to the FDA’s adverse event reporting system, the ISMP found that Invokana received more serious adverse event reports than 92% of the other drugs regularly monitored by the group.

Given the emerging safety concerns and rush to market this new class of diabetes drug, some product liability lawyers are now reviewing whether individuals who suffered an injury may be entitled to financial compensation through an Invokana lawsuit or Farxiga lawsuit as a result of the drug makers’ failure to adequately research the potential risks and warn about the side effects.