The Invokana lawsuit claimed the maker of Invokana failed to warn patients and physicians of the increased risks of amputations, ketoacidosis and kidney failure.
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Why Were Invokana Lawsuits Filed?
The Invokana lawsuits filed against Johnson & Johnson and Janssen Pharmaceuticals were combined before a federal judge in New Jersey where all discovery took place. The Invokana court proceedings were known as the Invokana Multi-District Ligitation.
The Key Legal Issue
Plaintiffs claimed that Invokana caused them to suffer amputations, kidney damage, and/or ketoacidosis. Yet, the makers of Invokana failed to warn doctors and patients of these potential side effects.
Invokana Injuries & Side Effects
The most serious potential risks caused by Invokana are amputations, kidney damage, and ketoacidosis.
Clinical trials have found that patients taking Invokana are twice as likely to suffer a leg or foot amputation as those taking a placebo. Toe amputations and those in the middle of the foot are most common. Individuals taking Invokana should be especially careful to look for signs of increased tenderness, sores, ulcers, and infections in their legs and feet; and to immediately notify their doctors if such symptoms appear.
Kidney failure occurs when a person's kidneys stop functioning without the use of dialysis or a kidney transplant. Kidneys help filter waste products from the blood, and help to control blood pressure, electrolyte balance, and red blood cell production. When kidneys stop functioning properly, waste products, fluids, and electrolytes build up and can cause weakness, shortness of breath, lethargy, confusion, abnormal heart rhythms and sudden death.
Ketoacidosis is a medical condition where high levels of ketones are produced in the body. Ketoacidosis can result in a patient suffering a diabetic coma, extended hospitalization, and even death. Ketoacidosis develops when insufficient levels of insulin are produced within the body. Without adequate insulin, the body breaks down fat as an alternative source of energy, which causes a buildup of toxic acids in the bloodstream called ketones.
FDA Invokana Warnings
Just over a year after Invokana's approval, the Institute for Safe Medication Practices issued a report indicating a link between kidney damage, renal failure, and SGLT2 inhibitors. The following year, the FDA issued a warning that Invokana and similar SGLT2 inhibitors can cause ketoacidosis.
Recently, researchers at the University of Padova in Italy analyzed reports voluntarily submitted to the United States FDA adverse-event reporting system. The analysis looked at 66 reports of amputations associated with SGLT2-inhibitors. Among those cases, 86% involved patients who had been taking Invokana. Two-thirds of those patients had no other apparent risk factors associated with amputations, such as nerve damage, injuries, infections and/or a previous history of amputation.
Since May 2017, the FDA has required Invokana to warn of this problem, advising doctors to discontinue Invokana for patients who experience unusual pain, sores or infections in the extremities.
Is Invokana Safe During Pregnancy?
Invokana has been classified by the FDA as pregnancy risk category C. Although no human tests are available to assess its risks, in rat fetuses this drug damaged kidney development. Traces of this drug were found in the milk of lactating rats, meaning that breastfeeding mothers should talk to their doctors before taking it.
On September 2015, the FDA modified the drug’s label to warn patients about a possible risk of bone fractures. Clinical studies showed an increased occurrence of fractures as early as 12 weeks after treatment initiation. The drug has also been linked to decreases in bone mineral density at the hip and lumbar spine, causing the bones to break even after a minor trauma is sustained.
Invokana Recall & Warnings
As of June 2018, there has not been a recall of Invokana related to amputations, kidney failure, myocardial infarction, or ketoacidosis.
However, the FDA had issued three safety announcements warning patients about these potential injuries, and has mandated that a Box Warning be prominently displayed describing the link between Invokana and amputations.
Beginning in 2017, Sharp HealthCare, Scripps Health, and numerous treating physicans stopped prescribing Invokana in light of the amputation risks.
What is the Purpose of Invokana?
Invokana is a prescription medication used in combination with diet and exercise to lower blood sugar and improve glycemic control in adults with type 2 diabetes. It was first approved by the U.S. Food and Drug Administration (FDA) in March 2013, and is manufactured by Janssen Pharmaceuticals, Inc.
When untreated, type 2 diabetes can lead to serious problems, including blindness, nerve damage, kidney failure, heart disease, stroke, high blood pressure, and a range of other problems. Invokana helps lower a person's blood sugar by causing the kidneys to remove sugar through the urine.
Invokana is an antidiabetic drug of the subtype 2 sodium-glucose transport (SGLT-2) inhibitors class. It helps improve glycemic control in patients with type 2 diabetes, and it’s often used in combination with other drugs such as metformin or sulfonylureas.
Invokana differs from its competitors by inhibiting the action of SGLT1, which causes glucose to remain in the intestinal tract, making it more effective in controlling blood sugar levels.
Patients affected by type 2 diabetes slowly become more and more resistant to the effects of insulin, a hormone required by cells to properly use glucose (blood sugar). Since cells cannot use sugar anymore, it starts reaching toxic levels in the blood, leading to a condition called hyperglycemia.
Many antidiabetic medications act by reducing the serum sugar levels or by improving the effectiveness of insulin itself. SGLT-2 inhibitors mechanism of action is a quite peculiar one. They block glucose kidney reabsorption, meaning that the sugar that reaches the kidney cannot go back to the blood and is thus eliminated through the urines.
Sugar removed this way amounts to an average of about 119 grams (476 kilocalories) per day. Since the glucose molecule possesses osmotic properties, additional water is excreted through diuresis reducing blood pressure.
Difference between Type 1 and 2 Diabetes
Type 1, also known as “childhood onset,” is a genetic condition in which the patient’s pancreas fails to produce insulin. Essentially, the organ does not function.
Type 2 is also known as “adult onset.” While some people are genetically predisposed to this condition, it is largely caused by lifestyle issues, such as obesity, excess consumption of sugar and lack of physical activity. While the pancreas is usually fully functional, the body’s cells have stopped responding to insulin. The condition is known as “insulin resistance.”
Invokana Lawsuit News
FDA warns of foot, leg amputations with J&J diabetes drug:
"Johnson & Johnson is required to add new warnings to its diabetes drug, Invokana, about the risk of foot and leg amputations, the U.S. Food and Drug Administration said on Tuesday." Reported in Reuters - FDA Invokana Amputation Warnings
Perspective: SGLT2 inhibitors may predispose to ketoacidosis:
Based on the physiology of SGLT2 and pharmacology of SGLT2 inhibitors, there are several biologically plausible mechanisms whereby this class of drugs has potential to increase the risk of developing diabetic ketoacidosis. Future research should be directed toward identifying which patients are at greatest risk for this side effect, and also to optimizing pharmacotherapy in order to minimize risk to patients. Reported in The Journal of Clinical Endocrinology & Metabolism - Invokana and Ketoacidosis
Understanding SGLT2 Inhibitors' Diabetic Ketoacidosis Risk:
"In May 2015, the FDA issued a warning about the risk of developing diabetic ketoacidosis while using SGLT2 inhibitors. That December, the FDA updated the drugs’ labels to include warnings about developing ketoacidosis even with near-normal blood glucose levels." Reported in Pharmacy Times - Invokana Ketoacidosis Risk
FDA Issues Warning for Type 2 Diabetes Drugs: SGLT2 inhibitors linked to potentially fatal condition called ketoacidosis:
A certain class of type 2 diabetes drugs can lead to a life-threatening condition called ketoacidosis, the U.S. Food and Drug Administration warns. These prescription drugs are called sodium-glucose cotransporter-2 (SGLT2) inhibitors and include canagliflozin, dapagliflozin and empagliflozin. They work by prompting the kidneys to remove sugar in the blood through urine. The drugs are sold under the brand names: Invokana (canagliflozin), Invokamet (canagliflozin and metformin), Farxiga (dapagliflozin), Xigduo XR (dapagliflozin and metformin extended-release), Jardiance (empagliflozin), Glyxambi (empagliflozin and linagliptin). Reported in WebMD - FDA Ketoacidosis Warning
FDA and Scientific Studies Regarding Invokana
FDA confirms increased risk of leg and foot amputations with Invokana
"Based on new data from two large clinical trials, the U.S. Food and Drug Administration (FDA) has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations." Reported in FDA Invokana Safety - Amputations
FDA strengthens kidney warnings for diabetes medicines Invokana, Invokamet, Farxiga & Xigduo XR
"The U.S. Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)." Reported in FDA Invokana Safety - Kidney Issues
FDA revises labels of SGLT2 inhibitors [including Invokana] to include warnings about too much acid in the blood and serious urinary tract infections
"Patients should stop taking their SGLT2 inhibitor [such as Invokana] and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones." Reported in FDA Invokana Safety - Infections