Medications

Invokana Lawsuit – Injuries and Death 

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The type 2 diabetes drug Invokana and other SGLT2 inhibitors have been linked to serious injuries and side effects such as:

  • ketoacidosis
  • kidney failure
  • heart attack
  • heart failure
  • diabetic coma
  • hydrocephalus (fluid on the brain)

How Do I File an Invokana Lawsuit?

If you or a loved one took Invokana or another SGLT2 inhibitor and suffered any of these serious injuries or died, you may be entitled to a cash award and compensation for medical expenses. For a free confidential consultation with Invokana lawyers at our law firm, please call 1.800.988.8005 or submit an email inquiry above.

About Invokana and Other SGLT2 Inhibitors

SGLT2 (sodium-glucose cotransporter-2) inhibitors, such as Invokana, are a class of prescription medicines that are FDA approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine.

Brand name Active ingredient(s)
Invokana canagliflozin
Invokamet canagliflozin and metformin
Farxiga dapagliflozin
Xigduo XR dapagliflozin and metformin extended-release
Jardiance empagliflozin
Glyxambi empagliflozin and linagliptin
Synjardy empagliflozin and metformin

 

FDA Drug Safety Warning Regarding Invokana and Other SGLT2 Inhibitors

[5-15-2015] The U.S. Food and Drug Administration (FDA) has warned that the type 2 diabetes SGLT2 inhibitors may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.

A search of the FDA Adverse Event Reporting System (FAERS) database identified reports of diabetic ketoacidosis (DKA) in patients treated with SGLT2 inhibitors. All patients required emergency room visits or hospitalization to treat the ketoacidosis. Since June 2014, the FDA has continued to receive additional FAERS reports for DKA and ketoacidosis in patients treated with SGLT2 inhibitors.

The FDA is continuing to investigate this safety issue. Additional reports of DKA continue to be submitted to the FDA, and they will determine whether changes are needed in the labeling for this class of drugs.

[12-4-2015] A FDA safety review has resulted in adding warnings to the labels of SGLT2 inhibitors about the risks of too much acid in the blood and of serious urinary tract infections. Both conditions can result in hospitalization.

A review of the FDA Adverse Event Reporting System (FAERS) database from March 2013 to May 2015 identified 73 cases of ketoacidosis in patients with type 1 or type 2 diabetes treated with SGLT2 inhibitors. FAERS includes only reports submitted to FDA, so there are likely additional cases about which we are unaware. All patients required hospitalization or treatment in an emergency department. In many cases, ketoacidosis was not immediately recognized because the blood glucose levels were below those typically expected for diabetic ketoacidosis. As a result, treatment of the ketoacidosis was delayed in some cases.

The FDA also identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections with the SGLT2 inhibitors reported to FAERS from March 2013 through October 2014. All 19 patients were hospitalized, and a few required admission to an intensive care unit or dialysis in order to treat kidney failure.

As a result, the FDA has added new Warnings and Precautions to the labels of all SGLT2 inhibitors to describe the two safety issues, and to provide prescribing and monitoring recommendations. The FDA is also requiring manufacturers of SGLT2 inhibitors to conduct a required postmarketing study. This required enhanced pharmacovigilance study requests that manufacturers perform analyses of spontaneous postmarketing reports of ketoacidosis in patients treated with SGLT2 inhibitors, including specialized follow-up to collect additional information, for a period of 5 years.

 

What is Ketoacidosis and what are the Symptoms?

DKA, a subset of ketoacidosis in diabetic patients, is a type of acidosis that usually develops when insulin levels are too low or during prolonged fasting. DKA most commonly occurs in patients with type 1 diabetes and is usually accompanied by high blood sugar levels. DKA causes the body to burn fatty acids instead of glucose, which produces excess ketone bodies. In turn, this condition raises blood acidity to dangerous levels.

Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.

 

How is Ketoacidosis Treated and what are the Complications?

Typical cases of ketoacidosis lead to an emergency visit or hospitalization, which can include insulin and electrolyte therapy, and IV fluids to correct dehydration and to reduce blood ketone concentration.

Complications may include cerebral and pulmonary edema (excess fluid in the brain and lungs), cardiac arrhythmias, severe low potassium, venous thromboembolism (blood clots in the legs and lungs), organ failure, heart attack, respiratory distress, diabetic coma, and death.

 

Kidney Failure

A review of the FDA adverse event database has demonstrated patients are several times more likely to report kidney failure than those not taking SGLT2 inhibitors. Higher dose animal studies in rats with uncertain applicability to human exposure showed long-term kidney damage.

In 2014 Q2, according to data from IMS Health, ISMP identified 457 serious adverse event reports, including 5 different adverse effects directly or indirectly related to the renal toxicity of Invokana. This included 54 events of kidney failure or impairment.

 

Cardiovascular Events

In January 2013, at a FDA Endocrinology and Metabolic Drugs Advisory Committee (EMDA) meeting discussing diabetes treatments, Dr. Sidney Wolfe, expressed the concern that thrombotic events (blood clots) could lead to heart attacks. Mr. Wolfe extrapolated data from a related class drug, Farxiga, to show that those on Invokana were 1.5 times more likely to have an increase in hematocrit that those on Farxiga.

Hematocrit is the concentration of red blood cells, which is increased by an SGLT2’s mechanism of action. According to Dr. Wolfe, at least 25% of patients on Invokana would have a red blood cell concentration of 47%, which is a very dangerous figure. Increases above normal concentrations of 40% for women and 45% for men increase the likelihood of stroke and heart attack.

FDA Reviewer Dr. Hyon Kwon testified that there was an “imbalance in early cardiovascular events” observed in the CANVAS trial, a 4,300 subject study evaluating the cardiovascular effects of Invokana. Dr. Soukop testified that in the first 30 days of use, Invokana had a 690% higher likelihood of suffering a cardiovascular event than those patients who were taking the placebo.

 

Invokana Lawyers Are Ready to Help

Levy Konigsberg LLP is currently accepting Invokana injury cases in all 50 states. If you or a loved one took Invokana or another SGLT2 inhibitor and suffered any of these serious injuries or died, you may be entitled to a cash award and compensation for medical expenses. For a free confidential consultation, please call one of our Invokana lawyers at 1.800.988.8005 or submit an email inquiry above.

Learn More

FDA Drug Safety Communication
ISMP 2014 Quarter 2 Report

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Note: Invokana® and Invokamet ™ are registered trademarks of Janssen Pharmaceuticals, Inc. Farxiga® and Xigduo XR™ are registered trademarks of the AstraZeneca group of companies. Jardiance® and Glyxambi® are registered trademarks of Boehringer Ingelheim Pharmaceuticals, Inc. These trademarks are for identification only. This law firm is not associated with, sponsored by, endorsed by or affiliated with Janssen Pharmaceuticals, Inc., the AstraZeneca group of companies, Boehringer Ingelheim Pharmaceuticals, Inc., or the U.S. Food and Drug Administration. Nothing on this site has been authorized or approved by the aforementioned.

 

For more information about the law firm's practice areas please contact Levy Konigsberg LLP at 1-212-605-6200 or 1-800-988-8005, 24 hours a day, 7 days a week.

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