What is Invokana?
Invokana (generic: canagliflozin) is used to control blood sugar levels in patients with type 2 diabetes. The drug works by increasing the removal of sugar through the kidneys. Invokana is a member of a new class of type 2 diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which also includes Invokamet (canagliflozin and metformin), Farxiga (dapagliflozin), Xigduo XR (dapagliflozin and metformin) and Jardiance (empagliflozin). Invokana is made by Janssen Pharmaceuticals (a Johnson & Johnson company), and was approved by the U.S. Food & Drug Administration (FDA) on March 29, 2013.
Why is Invokana Not Approved for Type 2 Diabetes?
Since Invokana works by increasing the amount of glucose that is excreted through the urine, its effect is independent of insulin. This is important as one of the main differences between type 1 and type 2 diabetes is that type 1 diabetics typically produce little to no insulin. So in theory, Invokana might work in patients with type 1 diabetes. The main question is how well and would it make much sense to use it on a patient who is already going to require insulin therapy. However, Invokana has not been studied in patients with type 1 diabetes, and remains approved only for the treatment of type 2 diabetes.
What are the Side Effects of Invokana?
Invokana and other SGLT2 inhibitors have been linked to the following serious side effects:
- Diabetic Ketoacidosis (DKA, Diabetic Acidosis, Metabolic Ketoacidosis, Ketoacidosis)
- Heart Attack (Myocardial Infarction or MI)
- Kidney Failure (Renal Failure) / Kidney Cancer / Kidney Infections (Pyelonephritis) / Kidney Stones
- Amputations of the leg, foot, toe
- Bone Fractures / Bone Abnormalities
- Testicular Cancer
- Urinary Tract Infections (UTIs)
- Severe Dehydration / Fluid Imbalance
- Abnormal Weight Loss
- Hypersensitivity (Allergic Response)
- Blood Infections (Urosepsis)
- Fungal Infections
- Yeast Infections (both men and women)
- And more
What is Diabetic Ketoacidosis?
Diabetic ketoacidosis is a life-threatening condition that occurs when cells in the body are unable to get the sugar (glucose) they need for energy because there is not enough insulin. When sugar can’t get into the cells, it stays in the blood. The kidneys filter some of the sugar from the blood and remove it from the body through urine.
Because the cells are unable to use sugar for energy, the body begins to break down fat and muscle. When this occurs, fatty acids called ketones are produced and enter the bloodstream, causing a chemical imbalance (metabolic acidosis) called diabetic ketoacidosis.
What are the Symptoms of Ketoacidosis?
Signs and symptoms of diabetic ketoacidosis tend to develop quickly, and may include:
- Excessive thirst
- Frequent urination
- Nausea and vomiting
- Abdominal pain
- Weakness or fatigue
- Shortness of breath
- Fruity-scented breath
Has the FDA Issued a Warning on Invokana?
On May 15, 2015, FDA issued a Drug Safety Communication indicating that SGLT2 inhibitor diabetes drugs had been linked to diabetic ketoacidosis. Between March 2013 and June 6, 2014, at least 20 cases of ketoacidosis in SGLT2 inhibitor users were reported to the FDA’s Adverse Events Reporting System (FAERS).
What About Amputations?
On May 18, 2016, FDA issued a warning about an increased risk of foot, leg and toe amputations associated with canagliflozin (the active ingredient in Invokana). The agency’s warning came in response to interim results of the ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS), which found that patients treated with canagliflozin were more likely to require an amputation compared to patients who took other types of drugs. Although the FDA acknowledged that additional studies are needed to determine whether canagliflozin is responsible for the increased amputation risk, it nevertheless advised patients to seek immediate medical attention if they experience pain, tenderness, sores, ulcers or infections in their legs or feet.
How Can Invokana Affect the Kidneys?
Because SGLT2 inhibitors affect normal kidney function so that sugars may be expelled through the urine, patients who use these medications may face a significantly increased risk of serious, potentially life-threatening kidney problems. In 2015, the Institute for Safe Medication Practices (ISMP) reported that a large percentage of the 457 adverse event reports linked to Invokana during its first year on the market were for kidney problems or renal failure.
Has There Been a Recall?
To date, no recall has been issued for Invokana or any other SGLT2 inhibitors. However, this is a relatively new class of medications and the investigation into their potential health risks is still in its early stages. It often takes many years and thousands of hours of attorney time for all the facts to come out about a drug that may ultimately lead to a recall.
What are Invokana Lawsuits Alleging?
Invokana lawsuits allege that Janssen failed to adequately warn doctors and patients about ketoacidosis, kidney damage, amputations, and other serious side effects that the drug may cause. The complaints state that had the manufacturer properly warned of these risks, patients would have been prescribed a different diabetes medication, and would have had their health monitored more closely for signs of health problems.
Are Cases Being Settled?
The first Invokana lawsuits were only recently filed, and the proceedings are still in their early stages. In all likelihood it will be several years before the manufacturer considers settling some or all of the complaints. However, our lawyers feel that J&J will eventually be required to pay substantial compensation as a result of their decision to place profits ahead of safety when they withheld information about Invokana’s potential health risks.
Is There a Class Action?
No class action lawsuit has yet been filed in the Invokana litigation, and it is doubtful that one will be certified for patients who were allegedly injured by the drug. However, if multiple lawsuits are filed against J&J alleging similar injuries from Invokana, these complaints may be consolidated into a multidistrict litigation (MDL) for pretrial handling. MDLs are different from class actions, and it is generally agreed that consolidating cases instead of proceeding in a class action is a more efficient way of handling claims arising from injuries associated with pharmaceutical products.
What Damages Could I Recover?
If our attorneys determine that you have a legitimate claim against Invokana’s manufacturer, you may be eligible to receive compensation for:
- Medical bills
- Disability / long-term injuries
- Lost wages
- Pain and suffering
- Wrongful death and funeral expenses
Additionally, if your lawsuit goes to trial, you may be awarded punitive damages if a jury decides to punish the manufacturer for wrongdoing.
How Long Do I Have to File a Claim?
Each state has a specific statute of limitations (SOL) regarding the amount of time plaintiffs have to file a lawsuit. If the complaint is not filed within this designated time frame, injured parties will be unable to file a lawsuit seeking compensation for their injuries. If you’ve been injured by Invokana, you should act now and contact our lawyers to protect your legal rights.