The Timeline of the Invokana® Lawsuit

About Invokana®

Invokana® is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that works by preventing the kidneys from reabsorbing sugar into the bloodstream. Typically, the kidneys release about 90 percent of glucose back into the bloodstream. Invokana® causes them to excrete more glucose through urine.

Invokana® is manufactured by Janssen Pharmaceuticals, a division of the Johnson & Johnson Corporation. Janssen also makes Invokamet®, which is a combination of canagliflozin and metformin, another diabetes medication. Invokamet® is prescribed for patients whose blood sugar levels are not adequately controlled with canagliflozin or metformin alone.

Adverse incidents filed with the FDA differed from typical diabetic ketoacidosis cases, because patients taking SGLT2 inhibitors did not present with elevated blood sugar.

Invokana®, the brand name for canagliflozin, is one of many drugs that has been introduced in recent years to treat type 2 diabetes. Invokana® was designed to help diabetics keep their blood sugar levels within a normal range, which can help prevent long-term complications from the disease.

Invokana® Complications

There have been more adverse events reported by users of Invokana® and Invokamet® than with any other SGLT2 inhibitors. Kidney failure and diabetic ketoacidosis are frequently reported by doctors and patients.

A patient is said to be in kidney failure when the organs stop removing waste products from the bloodstream. If the kidneys fail permanently, the patient will require ongoing dialysis or a transplant for treatment.

Diabetic ketoacidosis is characterized by a buildup of acid in the bloodstream. Ketones are acidic compounds that are produced as a byproduct of fat metabolism. When the body does not have a sufficient amount of glucose, it begins to break down stored fat. Without the appropriate treatment, diabetic ketoacidosis can lead to coma and even death.

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Other Invokana® complications reported by patients and their doctors include cardiovascular events, strokes, and bone fractures.

Invokana® Discovery Timeline

Discovery related to the Invokana® lawsuit has revealed evidence of substantiated health concerns regarding this medication. The following timeline provides an overview of relevant events and information pertaining to this litigation, and will be updated continuously as new information becomes available:

March 2013 - The U.S. Food and Drug Administration (FDA) approved Invokana®, and the drug was released to the market - the first in its class of SGLT2 inhibitors.

Mar 29, 2013 - A New York Times article was published about the new drug. The reporter noted that clinical trials had revealed signs of an elevated stroke risk, as well as an increase in heart attacks within 30 days of starting canagliflozin treatment. The article mentioned that the FDA ordered post-marketing clinical trials by Johnson & Johnson to further explore the complication risks. These safety studies are still ongoing.

December 10, 2013 - An article posted on Medpage Today reported on a study that was sponsored by Janssen Pharmaceuticals. The story was entitled, “Diabetes Drug Helps the Obese Shed Some Weight.” Although Invokana® was not FDA approved for weight loss treatment, the drug’s effectiveness for weight loss was promoted in advertising and on the product website.

August 2014 – The FDA approved Invokamet®. By this time, outpatient prescriptions for Invokana® numbered well over 400,000.

May 2015 - The FDA issued a safety warning about ketoacidosis complications associated with SGLT2 inhibitors. Adverse incidents filed with the FDA differed from typical diabetic ketoacidosis cases, because patients taking SGLT2 inhibitors did not present with elevated blood sugar. In these cases, ketoacidosis was harder to diagnose and thus more dangerous.  

May 6, 2015 - The Institute for Safe Medication Practices’ (ISMP) Quarter Watch publication warned about adverse reactions related to Invokana®. The nonprofit agency counted more than 450 serious adverse events that had been reported to the FDA in the first year of Invokana®’s release, more complications than 92 percent of other drugs being monitored by the ISMP. The report questioned whether canagliflozin’s clinical benefits outweigh the risks, noting that the drug had not been sufficiently tested to answer this question when it was initially approved by the FDA, and there was “increasing evidence that canagliflozin is associated with adverse effects in appropriate clinical use.”

August 2015 - A medical journal published a perspective regarding SGLT2 inhibitors and their potential to increase the risk of developing diabetic ketoacidosis. The researchers concluded that “there are several biologically plausible mechanisms whereby this class of drugs has the potential to increase the risk of developing diabetic ketoacidosis.”

September 2015 - The FDA requested an update to warning labels for SGLT2 inhibitors related to an increased risk of bone fractures and reduced bone mineral density. Fractures had been seen as early as 12 weeks after patients started taking this drug, and clinical trials showed that minor traumas were causing the injuries.

September 2015 - The first Invokana® lawsuit was filed in Canada by a woman who suffered kidney failure after taking the drug. Additional U.S. lawsuits also began to hit courtrooms at this time.

December 2015 - The FDA revised SGLT2 inhibitor labels to include warnings about too much acid in the blood (ketoacidosis) and risks of serious urinary tract infections. Their Drug Safety Communication noted cases of ketoacidosis with delayed diagnosis, as well as life-threatening blood infections (urosepsis) kidney infections, and kidney failure.

January 2016 - The ISMP published a Safety Alert update on Invokana® announcing 5,484 adverse events related to the drug had been reported to the FDA in 2015. The complication reports include kidney failure or impairment, kidney stones, UTI’s, and abnormal weight loss.

February 2016 - The European Medicines Agency announced precautions concerning SGLT2 inhibitors and warned patients about the risk of diabetic ketoacidosis.        

Contact Our Legal Team  

Our legal team is currently investigating claims by Invokana® and Invokamet® plaintiffs. We have experience with a large number of diabetes-related pharmaceutical liability cases, successfully representing clients who have suffered losses from prescription Actos®, Onglyza®, and more. Please contact our legal team today to schedule a free consultation.