Complications Leading to the Invokana® Lawsuit

Invokana® and Other SGLT2 Inhibitors

Type 2 diabetes can be a very dangerous condition if left untreated. Without medical interventions, diabetes can lead to potentially serious health conditions such as nerve damage, kidney failure, blindness, hypertension, heart disease, and stroke. SGLT2 inhibitors are prescribed to help control blood sugar and allow for management of the condition. Unfortunately for many patients, several diabetes medications, such as Actos®, Avandia, and Onglyza®, have been associated with lawsuits arising from complications.

The Invokana® lawsuit alleges that the companies that produce and market SGLT2 inhibitors failed to provide the appropriate warnings.

The Invokana® Lawsuit

The Invokana® lawsuit alleges that the companies that produce and market SGLT2 inhibitors failed to provide the appropriate warnings to both healthcare professionals and diabetic patients about the increased risks associated with taking these medications. Patients taking Invokana® or similar products have seen an increase in kidney problems, heart conditions, ketoacidosis, bone fractures, and other adverse health events. If the companies had provided the appropriate warnings to those involved, patients and doctors may have chosen to pursue another medication or have their health continuously monitored to prevent any further complications.

Complications and Symptoms Arising from Invokana®

The use of SGLT2 inhibitors has led to an increase of several adverse health events for many diabetic patients.

Diabetic Ketoacidosis

Among the more common complications linked to the use of SGLT2 inhibitors, diabetic ketoacidosis is a condition in which acids begin to build up in the bloodstream. Diabetic patients cannot produce an adequate amount of insulin to help move glucose into cells to produce energy. When this occurs, the body begins to break down fat for energy, which produces acid in the blood called ketones.

Symptoms of ketoacidosis can develop quickly, and may include:

• Excessive thirst
• Frequent urination
• Nausea
• Vomiting
• Abdominal pain
• Fatigue
• Confusion
• Shortness of breath
• Fruity-scented breath

If left untreated, ketoacidosis can lead to a loss of consciousness, and eventually can be fatal.

Kidney Failure

Kidney failure occurs when your kidneys are no longer able to filter waste products from the blood. When this function is lost, dangerous levels of waste can accumulate in the bloodstream, causing an imbalance in your chemical makeup. Symptoms of acute kidney failure can include:

• Decreased urine output
• Fluid retention
• Drowsiness
• Fatigue
• Confusion
• Nausea
• Chest pain
• Seizures

Kidney failure can lead to a number of serious health risks, including fluid buildup in the lungs, inflammation of the lining of the heart, permanent kidney damage, and death.

Heart Attack

Also called a myocardial infarction, this condition causes the permanent death of cells within the organ caused by restricted blood flow. When blood cannot reach the heart muscle, it does not receive the oxygen and nutrients that it needs to survive. While treatments have vastly improved over the years, this is still an extremely serious condition that can be fatal.

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Stroke

A stroke is similar to a myocardial infarction, except that blood flow is restricted to an area of the brain. Without the oxygen and nutrients carried by the blood, the affected brain cells begin to die off within minutes. This is a serious condition that requires immediate medical intervention.

Bone Fractures

There has been an increase in hip and spine fractures in patients who are taking SGLT2 inhibitors. Fractures to these bones can be especially dangerous because they leave the patient immobile for an extended period of time following the injury. Immobility may put the patient at risk of developing blood clots in the legs or lungs, and also increase susceptibility to pneumonia and other serious conditions.

FDA and Other Warnings About Invokana®

In May 2015, the Food and Drug Administration (FDA) issued a safety warning about diabetic patients who have been prescribed SGLT2 inhibitors. The safety warning was specifically concerned with the incidence of patients experiencing ketoacidosis after taking the medication. Typically, ketoacidosis is accompanied by high blood sugar levels that are easily identified by simple blood tests that diabetic patients frequently perform to monitor their glucose levels. The safety warning specifically cited the FDA Adverse Event Reporting System (FAERS) database which differentiated these incidents from typical cases. Patients who had been taking SGLT2 inhibitors had been experiencing ketoacidosis without elevated blood sugar levels, making the condition more dangerous because it was more difficult to diagnose.

Had they been properly warned, patients would have been monitored for any of the adverse health events to ensure their safety while on the medication.

In September 2015, the FDA moved to update the warning labels for SGLT2 inhibitors to include the increased risk of bone fractures and reduced bone mineral density.

In addition to the FDA warnings, the Institute for Safe Medication Practices (ISMP) has issued several warnings related to an increase in adverse events in patients taking these types of drugs. They specifically noted an increase in kidney failure or impairment, fluid imbalance or dehydration, kidney stones, urinary tract infections, and abnormal weight loss.

Who May be Affected?

Diabetic patients who were prescribed an SGLT2 inhibitor since 2013 and experienced any of the related complications may have been affected. It is important to remember that although there have not been any significant recalls initiated concerning these drugs, doctors and patients who were not properly warned about the potential dangers may have a claim. Had the manufacturers and marketers of these medications properly warned those involved, they might have made an alternative choice in their medications or therapies. Additionally, if patients had known of the inherent dangers and chose to take these drugs anyway, they likely would have been monitored for any of the adverse health events to ensure their safety while on the medication.

Multidistrict Litigation

Many people are familiar with class action lawsuits. These types of cases occur when a very small group of individuals represent the interests of a much larger group. The results obtained by the smaller group are legally binding on everyone involved in the case.

Currently, the Invokana® lawsuit is heading towards multidistrict litigation. In this type of trial, each case is treated individually, but many cases are combined into one district for the purposes of discovery. The results obtained in the combined bellwether trial are not legally binding to individual plaintiffs, but can be advantageous to all involved.

Typically in multidistrict litigation, the defense team of the manufacturers uses the bellwether trial to obtain a realistic view of their financial risk and develop different classifications of settlements to offer plaintiffs based off of their specific injuries.

Contact an Invokana® Lawsuit Attorney

If you have been prescribed Invokana® or one of the other SGLT2 inhibitor medications and experienced any related complications, it is imperative that you contact an experienced attorney immediately. Each state has different time requirements in which you must file a claim before you forfeit all rights to do so. By allowing this time period to lapse without taking legal action, the manufacturers and marketers of these medications can no longer be held liable for any complications that you may have experienced.