Invokana Injury Lawsuits: FDA Warnings

On March 20, 2013, the FDA approved the drug Invokana for the treatment of Type 2 diabetes. The drug was approved for use in conjunction with diet and exercise, and is also often used with other diabetes drugs such as metformin. Type 2 diabetes affects about 24 million people in the United States alone, and, left untreated, can lead to cardiovascular issues, loss of vision, kidney damage and nerve damage. Invokana was a completely new type of diabetes drug which worked as an inhibitor of sodium-glucose co-transporter 2, blocking the reabsorption of glucose by the kidneys. Following the approval of Invokana, other SGLT2 drugs, such as Jardiance, Farxiga, Glyambi and Xigduo XR were also approved and marketed. Many of these drugs, particularly Farxiga, have since suffered the same types of problems as Invokana, and are also facing litigation.  


The manufacturer of Invokana, Janssen—a subsidiary of Johnson & Johnson—conducted nine clinical trials, involving over 10,000 patients with Type 2 diabetes prior to gaining FDA approval. As a condition of the approval, the FDA required that Janssen conduct five Invokana FDA mandatory long-term studies. An Invokana cardiac health study was the first of the required studies, as well as an enhanced pharmaco-vigilance program which encompassed an Invokana pancreatic disease study, an Invokana cancer study and an Invokana liver study.  Two pediatric research studies and a bone safety studies round out the mandatory FDA post-market trials Janssen was ordered to conduct, however the results of these trials will not be available for at least two more years.


Side Effects of Invokana During Clinical Trials

The clinical trials already completed on Invokana showed the most common side effects of the drug were vaginal yeast infections and urinary tract infections. Invokana also has a significant diuretic effect, meaning many patients experience a sudden drop in blood pressure, resulting in dizziness or fainting. This can be a serious issue for older patients who could suffer a bone break from the most minor fall. Janssen claims the dizziness experienced by these patients generally decreases after the first three months of taking Invokana, however some patients continue to experience dizziness and fainting.


There was also an increased risk of cardiovascular disease among many patients taking Invokana during the first thirty days, after which that risk appeared to level out. In fact, thirteen patients taking the drug during the clinical trials suffered a stroke or heart attack, compared with only one patient who was given a placebo drugs. Invokana patients clearly show an increase in cholesterol, however since the cardiovascular findings were somewhat unclear, there were no warnings on Invokana labels regarding heart attack or stroke.


Invokana and the FDA

The FDA did require that Invokana labeling carry a caution regarding renal failure and kidney disease, but it was not until 2017 that a Black Box warning was added to Invokana labeling regarding the risk of foot and leg amputation. This Black Box warning informed individuals they could face a much higher risk of amputation after taking Invokana. The information came from two large clinical trials which demonstrated Invokana brought a significantly higher risk of foot and leg amputations—nearly twice as many. A Black Box warning is the highest level of warning by the FDA. The studies were conducted by J & J and are known as the CANVAS and CANVAS-R studies.


Since its approval, the FDA has also warned that Invokana carries an increased risk of ketoacidosis, a potentially fatal disease. After receiving an abnormally high number of adverse event reports from patients who suffered ketoacidosis after taking Invokana, the agency issued a Safety Communication on May 5, 2015. In 2016, the FDA strengthened the warning labels on Invokana reflecting evidence of the drug’s link to ketoacidosis, telling patients who noticed nausea and/or fatigue to immediately seek medical attention. The FDA then added a second new warning label to Invokana regarding severe urinary tract infections.


When reviewing adverse event reports, the FDA identified 19 patients who had contracted life-threatening blood and kidney infections which apparently began as “routine” UTIs, then spread to the kidneys or bloodstream. Also in 2015, the FDA published an announcement which warned patients and physicians that Invokana could potentially decrease bone density, especially in the hip and lower spine. Data pooled form nine clinical trials found a marked increase in bone fractures and broken bones among those taking Invokana, as well as broken shoulders, arms, hands and fingers. These breaks occurred as early as 12 weeks after patients began taking Invokana.


Similar Drug, Farxiga, Denied FDA Approval, Later Approved

A diabetic drug very similar to Invokana, Farxiga, was denied FDA approval in 2012, as the panel was concerned about an apparent five-fold increase in breast and bladder cancers among those taking Farxiga during the clinical trials. The manufacturer argued the increase breast and bladder cancers were the result of pre-existing cancers. At this time, co-developers Bristol-Myers Squibb and AstraZeneca were asked to provide more data about the drug’s risk-benefit profile. Later, in late 2013, Forxiga was approved by the FDA by a vote of 13-1, and a 10-4 vote in favor of an updated cardiovascular risk profile of the drug. Since that time Farxiga has been implicated in


Lifesaving Diabetic Drugs Not Without Risk

While diabetes drugs can be lifesaving, they are nonetheless among the four types of drugs responsible for two-thirds of all emergency room visits from older adults. Oral diabetes drugs were implicated in over 10% of ER visits, whether due to dosage problems, drug interactions or, in some cases, manufacturer negligence. The oldest class of diabetic drugs known as Biguanide drugs work by increasing insulin sensitivity. Metformin is one of the most common Biguanide drugs on the market. Thiazolidinedione diabetic drugs increase insulin sensitivity and decrease insulin resistance.


Avandia and Actos are in this class of drugs, however they have been linked to heart disease and bladder cancer. The third class of diabetic drugs are incretin therapy drugs and include Byetta, Januvia and Victoza. These drugs, once the “darling” of the diabetes drugs, have been shown to increase pancreatic cancer, and there are now a significant number of lawsuits against the manufactures of these diabetic drugs. The final class of diabetic drugs works through inhibiting sodium-glucose co-transporter 2.  Invokana, Xigduo XR, Glyambi, Jardiance and Farxiga fall in this class of drugs.


Getting Help from an Invokana Injury Lawyer

Although there has been no recall of Invokana, the drug has been linked to: ketoacidosis, myocardial infarction, kidney failure, kidney infections, kidney stones, testicular cancer, severe dehydration, amputations of toes, legs and feet, bone fractures, stroke, UTIs, blood infections, fungal infections, yeast infections, hypersensitivity and abnormal weight loss. Some of the current claims being made in Invokana lawsuits accuse Janssen and J & J of negligence, failure to warn, manufacture of a defective drug, and misrepresentation of the drug’s risks and benefits. Because there is a time limit to file your claim—known as the statute of limitations—it is extremely important that you seek legal advice from an experienced Invokana injury lawyer if you have been injured by Invokana or another SGLT2 drug. The attorneys of Sullo & Sullo can help you through this difficult time by carefully weighing your options, giving you the information you need, and ensuring your rights and your future are fully protected. Our Invokana injury lawyers have your best interests at heart, from start to finish.


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