An Increased Incidence of Diabetic Ketoacidosis in Invokana® Patients

Hundreds of plaintiffs are alleging serious and fatal complications connected to Invokana® and Invokamet®, as well as other similar sodium-glucose cotransporter-2 (SGLT2) inhibitor medications. If you or a loved one was prescribed Invokana® and experienced diabetic ketoacidosis of another complication, you may be entitled to significant compensation for your injuries. Please contact an experienced pharmaceutical attorney today to arrange a free consultation.

About Invokana®

Designed to help patients improve glycemic control, Invokana® works by causing the kidneys to remove sugar from the blood and excrete it through urine. Invokana® prevents the kidneys from reabsorbing glucose into the blood so that levels stay within the normal range, which is optimal for long-term health.

Diabetic ketoacidosis occurs when the body lacks sufficient glucose and begins to break down fat as a source of fuel.

Invokana® is a brand name for canagliflozin, marketed by Janssen Pharmaceuticals. It was approved by the U.S. Food and Drug Administration (FDA) in 2013, and marketed heavily to doctors and patients. The following year, Janssen introduced Invokamet® for patients who did not respond well to Invokana®. This medication combines canagliflozin and metformin, another type 2 diabetes drug, into a single tablet.

Although not approved by the FDA, these medications are occasionally prescribed to treat type 1 diabetes. Additionally, Janssen has promoted them as effective methods of weight and blood pressure control. Television advertising and the Invokana® website state that the medication “is not for weight loss, but may help you lose weight – on average three percent.” The website also states that Invokana® has “demonstrated superior reductions in body weight...”

Complications Reported

The FDA has received many reports of patients experiencing ketoacidosis after being prescribed Invokana® or another SGLT2 inhibitor, and issued a safety warning in May 2015. As of June 2014, the agency had already received reports of 20 diagnosed cases of acidosis, ketoacidosis, or ketosis, all resulting in patient hospitalization. The patients had been taking their prescription for an average of two weeks. Cases stemming from Invokana® use were uniquely dangerous because the patients had experienced ketoacidosis without elevated blood sugar levels, making the condition more difficult to diagnose.

The FDA later issued a Drug Safety Communication announcing revised SGLT2 inhibitor warning labels. All packaging for these medications now include warnings about ketoacidosis and serious urinary tract infections.

In addition to continuing reports of ketoacidosis, there have also been many reports of kidney damage and kidney failure, among other complications. The nonprofit Institute for Safe Medication Practices (ISMP) warned of 456 serious adverse event reports filed with the FDA within the first year of Invokana®’s release. In January 2016, the ISMP reported 5,484 adverse events associated with Invokana®, including 168 cases of diabetic ketoacidosis. They also noted that many cases go unreported, so the actual number of these complications is likely much higher.

In February 2016, the European Medicines Agency also issued a warning to patients and caregivers regarding SGLT2 inhibitors, including Invokana®. They specifically outlined concerns about the increased risk of diabetic ketoacidosis and encouraged careful monitoring of symptoms to minimize the risk of danger.

What is Diabetic Ketoacidosis?

Diabetic patients don’t produce an adequate amount of insulin to move glucose into cells and provide energy to the body. Diabetic ketoacidosis occurs when the body lacks sufficient glucose and begins to break down fat as a source of fuel. The metabolic process releases acidic compounds called ketones, which can accumulate and reach toxic levels in the bloodstream.

Diabetic ketoacidosis is most common in people with type 1 diabetes, but has been seen increasingly in type 2 diabetics who take certain medications. The onset of this condition can be very sudden, and the symptoms should prompt an immediate call for medical advice. Common symptoms may include:

• Excessive thirst
• Frequent urination
• Fruit-scented breath
• Nausea
• Vomiting
• Abdominal pain
• Fatigue
• Blurred vision
• Confusion
• Shortness of breath
• Loss of consciousness

Mild symptoms warrant a call to your doctor, but if you experience vomiting and trouble catching your breath, it may be necessary to go immediately to the emergency room. Diabetic ketoacidosis can be very serious, potentially leading to coma and even death.

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To diagnose ketoacidosis, the doctor will run a number of blood tests to analyze the levels of potassium, glucose, arterial gas, and amylase. Once the condition is confirmed, treatment will be administered to restore normal balance in the bloodstream.

Diabetic Ketoacidosis Treatment and Complications

Diabetic ketoacidosis patients are typically hospitalized while they receive the appropriate treatment. Many patients require intravenous fluids in conjunction with potassium and phosphates to restore normal levels in the bloodstream. Insulin therapy can be used to neutralize the accumulated ketones, returning the body to a normal pH range.

Many patients who receive timely treatment for diabetic ketoacidosis can expect to make a full recovery. Some patients, however, will experience additional complications. Hypokalemia is a condition characterized by low potassium levels. Potassium is instrumental in regulating heart rate, and any fluctuations in blood levels can cause arrhythmia and heart attack. Signs of hypokalemia include muscle cramps, weakness, constipation, and breathing difficulties.

Some patients will experience severe dehydration, which can lead to kidney failure and other concerns. Rapid, unpredictable changes in body fluid levels can cause acute respiratory distress syndrome. Breathing becomes increasingly difficult, and treatment with a ventilator may be necessary until the condition is stabilized. Cerebral edema, an excess of fluid that builds up in the brain, is also a potential complication of diabetic ketoacidosis. This condition is extremely rare, but also very dangerous with a 25 percent mortality rate.

Legal Remedies for Patient Losses

Many patients are pursuing legal action against Janssen Pharmaceuticals, a division of Johnson & Johnson. Plaintiffs accuse the company of manufacturing a defective product and failing to warn doctors and patients about the known potential risks. The timeline of Invokana® litigation begins with the first cases filed in September 2015. A class action lawsuit was filed in Canada, which now has dozens of claimants alleging damages from Invokana® complications.

It is important to pursue a claim prior to the expiration of the statute of limitations deadline in your home state.

In a U.S. lawsuit filed in December 2015, an Alabama woman claims she developed diabetic ketoacidosis after taking Invokana® and has suffered severe and permanent injuries. She claims that she was unaware of the risks associated with the drug and would have chosen an alternative therapy to manage her blood sugar if she had been informed. She accuses Janssen of marketing Invokana® for off-label purposes, including weight loss, reduced blood pressure and glycemic control for type 1 diabetics.

As the number of U.S. cases continues to grow, multidistrict litigation (MDL) looks increasingly likely. MDL combines numerous cases under the jurisdiction of a single judge, who oversees discovery and trial scheduling. In contrast to class action lawsuits, MDL allows plaintiffs to pursue an individual settlement with their selected attorney, and are not legally bound by other plaintiffs’ decisions.

Plaintiffs who have been left to contend with medical bills, income loss, and pain and suffering, can receive legal compensation for these damages. It is important to pursue a claim prior to the expiration of the statute of limitations deadline in your home state.

Contact a Pharmaceutical Injury Attorney

Our legal team is offering complimentary case evaluations for patients who experienced diabetic ketoacidosis or other complications after taking Invokana® or another SGLT2 inhibitor. Please contact an experienced pharmaceutical attorney today to explore your legal rights.