Invokana Lawsuit

In 2013 the FDA approved the first drug in a new class known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. Developed by Janssen Pharmaceuticals, Invokana (canagliflozin) was designed as a diuretic and prescribed to patients diagnosed with Type 2 Diabetes that could not be controlled by diet and exercise alone.

How Does Invokana Work?

Invokana lower’s the blood sugar level by triggering the kidneys to dispose of excess glucose through the urine. High concentrations of sugar in the bladder make it the perfect environment for bacterial growth and urinary tract infections to occur. However, UTIs aren’t the only concern stemming from Invokana. Because the drug relies so heavily on the kidneys, damage or even kidney failure can occur.

Dangers of Using Invokana

In clinical trials, patients on Invokana were significantly more likely to develop ketoacidosis than patients on other SGLT2 inhibitors. Ketoacidosis typically involves extremely elevated blood-sugar levels. However, many Invokana patients with normal or mildly-elevated blood-sugar have developed ketoacidosis. The unusual symptoms can delay diagnosis and treatment until it becomes life-threatening. Diabetic ketoacidosis, often called DKA, occurs when the body is unable to produce enough insulin and in turn breaks down fat as an alternative source of energy. This process causes a buildup of toxic acids in the bloodstream called ketones. Excess ketones result in ketoacidosis if untreated. High levels of ketones in the body can cause diabetic coma (passing out for a long time) or even death.

The most serious potential side effects to date include myocardial infarction or heart attack, limb amputation, and severely impair kidney functions. In clinical trials, 13 patients on Invokana had a heart attack or stroke during the first 30 days of treatment, compared to just one patient on a placebo although the risk normalized after 30 days. Data from the CANVAS clinical trial linked Invokana to a 46% increased risk of stroke in the first 30 days.

Due to these side effects, the U.S. Food and Drug Administration (FDA) is now requiring Invokana manufacturers to include a “black box warning,” the strictest possible warning that can be placed on pharmaceutical packaging.

FDA Warnings

In May 2015 the FDA intervened and issued a warning, stating Invokana and other drugs in its class may lead to diabetic ketoacidosis. In December 2015 the FDA addressed SGLT2 inhibitor manufacturers directly and ordered an update to drug label warnings, educating users of the risks for ketoacidosis and urinary tract infections.

Concerns have arisen that if the manufacturer had properly warned physicians and users of the risks, patients would have been prescribed a different medication for their diabetes, and certainly would have had their health monitored more frequently for potential signs of heart issues, renal compromise, and for the presence of ketones. There are questions whether the benefits of Invokana outweigh its potential risks. According to the Institute for Safe Medication Practices (ISMP) adverse effects linked to this drug were higher than 92 percent of all the drugs the healthcare group monitored. As of this time, there has not been a recall of Invokana related to kidney failure, myocardial infarction or ketoacidosis.

Should You File an Invokana Lawsuit?

The Kagan Law Firm is currently accepting cases involving limb amputations, the development of ketoacidosis, renal failure, urinary tract infections, due to the use of Invokana and Invokamet. If yourself or a loved one were harmed after taking these drugs or any other SGLT2 inhibitors, please contact our office today. Our attorneys will discuss your rights, as well as determine whether or not you have a case against one of the drug manufacturers.

We are dedicated to representing our clientele. Our legal team is driven by a commitment to provide the most exceptional service possible.

To discuss your potential case, please contact us at (239) 466-1161, or fill out the form below.