In March of 2013, the U.S. Food and Drug Administration (FDA) approved Invokana (canagliflozin) to treat Type 2 diabetes. Invokana is a new class of drug, an SGLT2 Inhibitor, which is a sodium glucose co-transporter 2 inhibitor. Invokana is manufactured by Janssen Pharmaceuticals, Inc., which is a subsidiary of Johnson & Johnson. SGLT2 inhibitors prevent high blood sugar by forcing the patient’s kidneys to remove excess sugar through urine excretion in an “emergency” evacuation mode. The drug became a blockbuster drug, generating at least $1 billion in sales, within two years of being on the market.
Invokana is a prescription medicine that is used along with diet and exercise to lower blood sugar. Invokana is normally taken in combination with another drug, like Metformin or Glucophage, to decrease insulin resistance, because Invokana alone does not lower blood sugars enough to make it an effective single agent for the treatement of diabetes. In studies, Invokana lowered A1C (a 3-month average of the amount of sugar in the blood) by only .5 to .7 percentage points, making it a weak glucose lowering agent. Invokana has also been prescribed for off label uses of lowering blood pressure and promoting weight loss.
Invokana was approved for sale by the FDA in a January 2013 Advisory Committee Meeting by an 8:7 vote. This drug barely passed the vote for approval by the Committee. The reason for the narrow margin for approval is because in the first month of clinical trials for Invokana, 13 participants receiving the drug had a heart attack or stroke and only one participant in the placebo group had a heart attack. Unbelievably, the Committee asked Janssen to continue studying the drug while at the same time approving the drug for sale to the general public. Adding to this already problematic scenario is the fact that Janssen’s Canagliflozin Cardiovascular Assessment Study (CANVAS) clinical trial, which commenced in 2009, is still ongoing at this time, and will not even be available until June of 2017.
Invokana has been linked to a number of serious side effects including diabetic ketoacidosis (DKA). DKA is a type of acidosis that develops when insulin levels are too low or during prolonged fasting. Complications of DKA include difficulty breathing, nausea, vomiting, abdominal pain, confusion and unusual fatigue or sleepiness. The condition can result in a diabetic coma, extended hospitalization and even death.
In a Diabetes Care Study published in September of 2015, Invokana was associated with a much higher risk of DKA than other SGLT2 inhibitors. From March of 2013, when Invokana was first approved, to October of 2015, the FDA received reports of 101 confirmable cases of acute kidney injury, some requiring hospitalization and dialysis. In approximately half of the cases, the acute kidney injury occurred within only one month of starting the drug.
The crux of claims against Janssen include failure to adequately test Invokana and properly warn consumers about the risk of medical problems associated with the drug. On May 15, 2015, the FDA issued a Safety Announcement warning that SGLT2 Inhibitors like Invokana may lead to diabetic ketoacidosis. On Dec. 4, 2015, the Safety Review conducted by the FDA resulted in the label being changed to warn of too much acid in the blood and that SGLT2 Inhibitors may cause serious urinary tract infections. On Sept. 10, 2015, the FDA strengthened the warning for SGLT2 Inhibitors to include an increased risk of bone fractures. On June 14, 2016, the FDA revised the warnings for SGLT2 Inhibitors to include information about acute kidney injury, specifically kidney failure.
Lawsuits have been filed in federal courts in California, Georgia, Illinois, Kentucky, Louisiana, Minnesota, New Jersey, and Tennessee. Lawsuits have also been filed in state courts in Illinois, Missouri and Delaware. On Dec. 7, 2016, the Judicial Panel on Multidistrict Litigation (JPML) issued an order consolidating 55 lawsuits against Janssen in New Jersey federal court. U.S. District Judge Brian R. Martinotti will preside over the multidistrict litigation (MDL), which will handle Invokana and Invokamet cases only. The MDL litigation is In Re Invokana (Canagliflozin) Products Liability Litigation, MDL No. 2750.
Lawyers in Beasley Allen’s Mass Torts Section are investigating claims on behalf of individuals and families injured by Invokana and Invokamet, specifically cases involving diabetic ketoacidosis and acute kidney injury. If you would like more information, contact Danielle Ward Mason, a lawyer in the Mass Torts Section. She can be reached at (800) 898-2034 or by email at Danielle.Mason@BeasleyAllen.com.
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