Invokana and DKA Lawsuit

First available to the U.S. market in 2013, Janssen Pharmaceutical’s diabetes drug Invokana was considered a revolutionary improvement for Type 2 diabetes management. The Johnson & Johnson subsidiary announced its new product as an “important [and] much-needed” development in the fight against type 2 diabetes. Forbes acclaimed the drug’s “market potential,” while highlighting Invokana’s ability to “attack blood sugar right from the get go.”

The US Food & Drug Administration praised Invokana as an “advance [in] innovation.” Invokana’s market potential soared, with approximately 2 million prescriptions written in 2014 alone Unfortunately, the FDA soon had to admit the truth – that Invokana was found to be the cause of serious complications including ketoacidosis.

Call us today at 713-893-8808 or contact us online to discuss an invokana and DKA lawsuit.

Is Ketoacidosis Caused by Invokana?

According to an FDA Safety Announcement released on May 15, 2015, Invokana and other similar drugs “may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.” Less than a year later, the FDA added a new warning to Invokana’s label. Physicians were advised to immediately discontinue Invokana in patients with signs and symptoms of ketoacidosis.

Invokana was the first of a new class of drugs known as SGLT2, or sodium-glucose cotransporter-2, inhibitors. Invokana has been proven to cause ketoacidosis, according to the FDA.

In response to recent developments, patients who experienced ketoacidosis after taking Invokana, many of whom face costly medical bills, lost work and considerable suffering, have begun to file lawsuits.

What Is Ketoacidosis or DKA?

Ketoacidosis develops due to elevated “ketones,” or blood acid levels.

Generally, the body’s primary energy source comes from glucose, a type of sugar. Cells use a hormone called insulin to convert glucose into cellular energy. However, for patients with type 1 diabetes, the body cannot produce insulin. As a result, cells can’t break down blood sugars, and the body uses fat as its main source of energy.

The body relies on fatty acids for energy, which can be broken down by the liver to produce “ketones.” Ketones help fuel cells, but they’re still acids, and over time, excessive ketone production (or “ketosis”) builds up and poisons the blood. The blood’s pH level, a measure of acidity, becomes imbalanced and uncontrolled, leading to a potentially fatal medical condition: ketoacidosis.

Symptoms & Long-Term Complications of Ketoacidosis

Ketoacidosis can be fatal if left untreated. Patients taking Invokana are advised to report new symptoms to their health care professional, including:

Difficulty breathing
Flush, hot, or dry skin
Blurred vision, a result of wildly oscillating glucose levels, which causes fluids in the eye to increase and decrease rapidly
Extreme thirst and frequent urination
Nausea and / or stomach pain
Vomiting (especially vomiting lasting longer than 2 hours)
Fatigue, disorientation, and confusion

Ketoacidosis is often detected by loved ones who notice a strong, fruity scent on the patient’s breath. The smell is due to elevated levels of acetone, a type of ketone.

Diabetic ketoacidosis is a life-threatening medical emergency. Most patients require hospitalization and treatment including a combination of intravenous fluids, electrolytes, and insulin. Insulin delivers glucose to cells, reducing the body’s reliance on fat for energy, which lowers the ketone levels.

However, available treatments can cause other serious long-term complications:

Hypoglycemia, or low blood sugar, may result from the insulin dosage. For people with diabetes, low blood sugar alone can be fatal. Seizures and permanent neurological damage may develop over time because of hypoglycemia.
Hypokalemia, or low blood potassium levels, can occur after administration of necessary IV fluids and insulin. Muscle pain, cramps, and psychological symptoms including depression and hallucinations, as well as a worsening of glycemic control are all potential complications of hypokalemia.

In addition, cerebral edema, a swelling in the brain, can be caused by sudden decreases to the blood’s glucose levels.

Ultimately, diabetic ketoacidosis can lead to coma and death if it goes untreated.

Although Rare for Type 2 Diabetes Patients, Risks Are High for Invokana Users

Since patients with type 1 diabetes cannot use blood glucose for energy, their bodies almost always turn to fatty acids for fuel. As a result, ketoacidosis is common among these patients, known as “diabetic ketoacidosis” (DKA).

The American Diabetes Association considers diabetic ketoacidosis a “cardinal feature of type 1 diabetes.” Many young patients are diagnosed with type 1 diabetes after being hospitalized for the symptoms of DKA.

Invokana is not approved to treat type 1 diabetes. Invokana is only approved to treat type 2 diabetes and is not recommended for patients suffering from DKA.

Diabetic Ketoacidosis Is Rare for Patients with Type 2 Diabetes

Dangerously low insulin levels are what leads to diabetic ketoacidosis, as seen in patients with type 1 diabetes. But people with type 2 diabetes have no trouble producing insulin; their cells can’t convert glucose to fuel. As a result, diabetic ketoacidosis will not develop.

Until recently, cases of DKA in type 2 patients were so rare that the medical community believed the condition only occurred in patients with type 1. Now that serious complications involving Invokana patients (all diagnosed with type 2 diabetes) have been reported including ketosis, ketoacidosis, and diabetic ketoacidosis, the FDA took immediate notice.

Risks of Taking Invokana Announced

Between March 2013 and early June 2014, the FDA received 20 reports of diabetic ketoacidosis, ketoacidosis, or ketosis among patients taking SGLT2 inhibitors like Invokana. All cases involved hospitalization or emergency medical services, as did some 50 other cases identified between 2014 and May 2015.

It was discovered that a high number of type 2 diabetics were experiencing ketoacidosis, and all had been prescribed Invokana. But there was another, specific anomaly that would ultimately tip the FDA off to Invokana’s role in diabetic ketoacidosis.

While DKA is normally associated with elevated blood sugar levels in type 1 patients, the type 2 patients suffering from ketoacidosis had “only slightly increased [glucose levels] compared to typical cases of DKA.” This second abnormality led the FDA to conclude that patients weren’t just suffering from normal ketoacidosis, but that a common trigger caused it. And what did all the patients have in common? They were all taking SGLT2 inhibitors.

Since the discovery of adverse outcomes for multiple patients, the FDA has warned Invokana patients closely monitor themselves for symptoms of ketoacidosis. The FDA continues to get adverse event reports and has increased warnings on labels for all SGLT2 inhibitor drugs.

Consider Taking Legal Action on your Invokana and DKA

If you took Invokana and experienced ketoacidosis, you may be entitled to compensation. Contact Chelsie King Garza today for a free consultation. There’s no charge and no obligation, call to get the answers you need. Call now, 713-893-8808 or contact us online.