Invokana (canagliflozin) is a type 2 diabetes treatment designed to help lower blood sugar. Approved in March 2013 by the FDA, the blockbuster medication has brought in for Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, an estimated $1 billion in annual sales. However, since Invokana’s entry to the market, some patients have reported severe side effects such as kidney failure, heart attacks, strokes, and increased blood acid levels, or ketoacidosis. Symptoms of ketoacidosis include difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue. Lawsuits have been filed against Janssen and Johnson & Johnson regarding Invokana, alleging that the manufacturers failed to properly study the drug’s effects and adequately warn patients of its dangerous risks.
Invokana is the most popular drug in its class of sodium-glucose costransporter-2 (SGLT2) inhibitors, which includes other drugs such as Farxiga, Xigduo XR, and Jardiance. They reportedly work by blocking the kidneys’ reabsorption of glucose and eliminating excess blood sugar through urination in type 2 diabetes patients. If left untreated, type 2 diabetes can lead to serious problems, including kidney damage and heart disease.
On May 6, 2015, a new drug safety report was issued by the Institute of Safe Medication Practices addressing Invokana and whether or not enough clinical information was available to discern whether the drug’s benefits truly outweighed its risks. Just a few days later, the FDA issued a drug safety communication warning that Invokana and other SGLT2 inhibitors may raise acidity of the blood and result in hospitalization. The warning indicates that, “A search of the FDA Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014. All patients required emergency room visits or hospitalization to treat the ketoacidosis. Since June 2014, we have continued to receive additional FAERS reports for DKA and ketoacidosis in patients treated with SGLT2 inhibitors.” Further, according to a report outlining a study presented by Dr. Fraser W. Gibb of the Edinburgh Centre for Endocrinology & Diabetes at the American Diabetes Association 2015 Scientific Sessions, diabetic ketoacidosis resulting in hospitalization had a 10% increased risk of death within five years, and a 30% increased risk within six years if hospitalized more than four times.
Following the FDA’s warning and several reports from Canadian patients identifying similar side effects from Invokana, Health Canada issued its own safety update. Concerns over Invokana’s side effects have spread even further than North America, as the European Medicines Agency recently announced that SGLT2 inhibitors, including Invokana, have been added to its list of drugs that will be subject to additional monitoring due to over 100 cases of diabetic ketoacidosis being reported.
What Does This Mean for You?
If you experienced kidney failure or ketoacidosis while taking Invokana, you may be legally entitled to compensation.
Want to Know if You Have a Valid Legal Claim?
Experienced attorneys are investigating the risks of Invokana and are monitoring all developments. If you have experienced kidney failure or ketoacidosis while taking Invokana, please contact us by submitting the form or by calling us at 888-973-6379 for a confidential evaluation of your potential claim.