Invokana® lawsuits claim the manufacturer failed to warn patients and physicians of the increased risks of kidney failure, ketoacidosis, leg and foot amputations, and myocardial infarction (heart attacks). Our law firm is accepting clients who took Invokana® and suffered injuries. If you or a loved one was prescribed Invokana® and suffered serious side effects, contact us today to receive a free consultation from one of our firm’s experienced injury attorneys.
Invokana® (generic: Canagliflozin) is an oral diabetes medication prescribed to treat diabetes type 2 by helping control blood sugar levels. It was first approved by the U.S. Food and Drug Administration (FDA) in March 2013, and is manufactured by Janssen Pharmaceuticals, Inc. Some side effects faced by patients treated with Invokana® include ketoacidosis and kidney damage, and an increased risk of leg and foot amputations, a side effect patients were never warned about. Other common side effects of Invokana include:
These side effects are more likely to occur in older adults, and Invokana® also make patients more likely to suffer from bone fractures (even from minor impact trauma).
Invokana® is a member of the gliflozin class of pharmaceuticals, also known as sodium glucose co-transporter 2 (“SGLT2”) inhibitors. SGLT2 inhibitors, including Invokana®, prevent glucose from being reabsorbed by the kidneys and allows glucose to be excreted through the urinary tract. In other words, Invokana® lowers blood sugar by helping the kidneys remove sugar from the bloodstream through the urine. Patients taking Invokana® are several times more likely to report diabetic ketoacidosis than those taking non-SGLT2 diabetes drugs to treat diabetes.
Diabetic ketoacidosis (DKA) is a serious diabetes complication that arises from the body producing an excess amount of blood acids called “ketones”, which are produced when the body’s cells receive insufficient energy from glucose and begin to break down fat for it’s energy source. When there are too many ketones in the blood, it begins to acidify and becomes extremely harmful to the body. DKA can send a patient’s body into a diabetic coma and in the worst cases, can be fatal.
In May 2015, based on 20 reported cases of DKA, the U.S. Food and Drug Administration (FDA) warned that Invokana® (and other SGLT2 inhibitors) can potentially lead to DKA, and in December 2015, they took action to declare that all SGLT2 inhibitors would be required to display warnings about the risk of excessive blood acids, causing DKA. The FDA later added that the drugs also must warn against serious UTI’s (urinary tract infections). This major revision instructed physicians to immediately discontinue the drug in patients with signs and symptoms of ketoacidosis. Symptoms of DKA include nausea, vomiting, abdominal pain, fatigue, difficulty breathing and breath smelling of fruit.
Since Invokana® (and all SGLT2 inhibitors) puts heavy stress on the kidneys and promote urine production, it is not recommended for those who have defective kidney function. Though kidney injury is mentioned in Invokana® prescribing information, the manufacturers of the drug likely did not give sufficient warning about the severe renal side effects when the drug initially hit the market, and were later urged to strengthen their kidney injury warnings. In 2015, the Institute for Safe Medication Practices (ISMP) published a report listing more than 450 Invokana® adverse events including:
The ISMP raised questions about whether Invokana® had been sufficiently tested and whether its benefits outweigh its risks. The report stated, “The current data are insufficient to address unanswered questions raised in the FDA reviews about whether long-term use might result in a steady decline in kidney function.” In approximately half the cases used to generate this report, signs of acute kidney injury developed within 30 days of patients beginning to use the drug, and most patients’ kidney health improved once they were off the drug.
Since diabetes is known to increase the risk of cardiovascular complications and stroke, all new diabetes medication approved in the U.S. must be clinically tested for cardiovascular risks. When Invokana® was approved, there was controversy over a suspected increase of heart attacks and strokes among their clinical trial patients. One study even showed that the drug caused 13 cardiovascular events compared to just one within the placebo group. When taken to a vote, eight out of fifteen panel members expressed concerns over cardiovascular risks (strokes, in particular) citing insufficient data. However, the FDA panel voted 10 to 5 to approve the drug.
Despite clear concern about Invokana’s® likely potential to cause cardiovascular issues, the drug is being prescribed to hundreds of thousands of patients across the country and has generated approximately $1.5 billion per year for its manufacturer Janssen. Additionally, Invokana® surprisingly has no listed warnings about its cardiovascular side effects.
Thus far, thousands of patients have filed lawsuits, accusing the drug’s manufacturer of purposely concealing crucial medical evidence of the drug’s severe health risks from the public and the healthcare community. The lawsuits are presently combined before a federal judge in New Jersey where all of the national discovery and evidence gathering is taking place. With allegations quickly mounting, our experienced personal injury attorneys are diligently investigating potential lawsuits to be filed. If you or a loved one were injured in any way from taking Invokana®, you may be entitled to financial compensation for your injuries and medical expenses through a lawsuit. Contact our attorneys at My Vaccine Lawyer immediately, we will be more than happy to help you determine if you have an Invokana® lawsuit that is worth pursuing (800) 229-7704.
Page last reviewed and updated: November 20, 2019