SGLT2 inhibitor diabetes drugs including Invokana and Invokamet have been linked to diabetic ketoacidosis (DKA), a life-threatening condition that occurs when cells in the body are unable to get the glucose they need for energy. If left untreated, DKA can lead to diabetic coma (passing out for a long period of time) and even death.
Free Confidential Lawsuit Evaluation: If you or a loved one was diagnosed with ketoacidosis after taking a diabetes medication, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Update: Invokana Lawsuits Consolidated in New Jersey
December 19, 2016 - The U.S. Judicial Panel on Multidistrict Litigation (JPML) has ordered that all federal lawsuits alleging kidney failure and diabetic ketoacidosis from Invokana and Invokamet will be transferred to the District of New Jersey for pretrial handling before Judge Brian R. Martinotti. J&J and Janssen currently face about 55 such complaints in courts across the U.S. However, it is expected that this number will grow into the hundreds or even thousands by the time the litigation process is complete.
FDA Warns of Ketoacidosis Risk with SGLT2 Inhibitors
On May 15, 2015, the U.S. Food & Drug Administration (FDA) issued a warning [1] about an increased risk of diabetic ketoacidosis with the sodium–glucose cotransporter 2 (SGLT2) inhibitor class of type 2 diabetes medications. FDA’s Adverse Event Reporting System (FAERS) found at least 20 reports of the condition in patients treated with the drugs between March 2013 and June 6, 2014.
Diabetic ketoacidosis does not usually occur in type 2 diabetics, and the case presentations were “atypical in that glucose levels were only mildly elevated at less than 200 mg/dL in some reports, while patients with type 1 diabetes who have DKA typically have glucose levels greater than 250 mg/dL,” the agency said.
As a result of these problems, FDA in December 2015 updated the labeling of SGLT2 inhibitors [2] to include a warning about diabetic ketoacidosis.
Which Drugs are SGLT2 Inhibitors?
SGLT2 diabetes drugs that may increase the risk of diabetic ketoacidosis include:
- Invokana (canagliflozin)
- Invokamet (canagliflozin/metformin)
- Farxiga (dapagliflozin)
- Glyxambi (empagliflozin and linagliptin)
- Jardiance (empagliflozin)
- Xigduo XR (dapagliflozin and metformin hydrochloride extended-release)
DKA Symptoms
When cells don't get the sugar (glucose) they need for energy, the body begins to break down fat. This process creates chemicals called “ketones” that make the blood acidic. The more acid in the blood the greater the risk that ketoacidosis will result.
DKA usually develops slowly; however, when vomiting occurs, the condition can develop within hours.
Early symptoms include:
- Thirst or a very dry mouth
- Frequent urination
- High blood glucose (blood sugar) levels
- High levels of ketones in the urine
Later symptoms may include:
- Fatigue
- Dry or flushed skin
- Nausea, vomiting, abdominal pain
- Difficulty breathing
- Fruity odor on breath
- Confusion / hard time paying attention
It is important to remember that DKA is a serious medical condition. If you or a loved one has any of the symptoms listed above, call a doctor immediately or go to the nearest hospital emergency room.
How Do I Check for Ketones?
Ketones can be detected with a simple urine test strip, similar to a blood testing strip. Many experts advise to check your urine for ketones when blood glucose is over 240 mg/dl, according to the American Diabetes Association (ADA) [3]. Also, check for ketones when you have any symptoms of ketoacidosis.
Complications
If left untreated, ketosis can result in a number of serious health complications including:
- Cerebral edema (swelling and fluid buildup in the brain)
- Heart attack
- Blood clots
- Extremely low blood pressure
- Intestinal tissue damage due to lack of blood-flow
- Kidney failure
- Diabetic coma
- Death
Do I Have a Diabetic Ketoacidosis Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in diabetes drug diabetic ketoacidosis lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Case Evaluation: Again, if you got ketoacidosis from a diabetes drug, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.
