The type-2 diabetes drug Invokana has been linked to dozens of reports of diabetic ketoacidosis (too much acid in the bloodstream) and other severe side effects, including kidney failure, infections, bone fractures, and more.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Invokana induced injury cases in all 50 states. If you or somebody you know was diagnosed with a severe side effect, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
Lawyers Request Invokana MDL in New Jersey
September 20, 2016 — Lawyers have asked a panel of federal judges to centralize 56 Invokana lawsuits in a Multi-District Litigation (MDL) in New Jersey under U.S. District Judge Brian R. Martinotti. Click here to read more.
FDA Warning: Invokana and Kidney Injury
In June 2016, the FDA strengthened warnings about acute kidney injury from Invokana, which can cause the kidneys to suddenly stop working. The agency received 101 confirmed cases of acute kidney injury from March 2013, when Invokana was approved, until October 2015.
FDA Warning: Invokana Foot and Toe Amputations
In May 2016, the FDA warned that Invokana was associated with a doubled increased risk of leg and foot amputations in an ongoing clinical trial. Preliminary data from the CANVAS study found that 7 in 1,000 patients on Invokana (100-mg/day) had amputations, compared to 3 in 1,000 on a placebo. Click here to read more.
A growing number of lawsuits have been filed against Janssen Pharmaceuticals by people who were diagnosed with diabetic ketoacidosis after taking Invokana. One of the first lawsuits was filed October 28, 2015 in Illinois by man who was diagnosed with ketoacidosis after taking Invokana (Case No 3:15-cv-01195).
Kidney Failure Lawsuits
Janssen is also accuse of downplaying the risk of kidney failure. The label on Invokana merely indicates that a “possible side effect” of Invokana is “kidney problems.” Lawyers say these warnings are inadequate because they do not specifically address the risk of kidney failure or the extent of the risk associated with Invokana:
- March 31, 2015: Lawsuit (PDF) filed in state court in Delaware by a woman from Tennessee who was diagnosed with severe, life-threatening side effects of kidney failure.
- February 29, 2016: Lawsuit (PDF) was filed in federal court in California by a woman who was hospitalized with kidney failure in March 2015.
- February 19, 2016: Lawsuit (PDF) filed in Kentucky by a woman who was hospitalized with kidney failure in February 2015.
- December 14, 2015: Lawsuit (PDF) filed in Tennessee by a man who started taking Invokana in November 2013 and developed kidney failure (Case No. 2:15-cv-02799).
What is Invokana?
Invokana (canagliflozin) is a prescription drug for people with type-2 diabetes that helps prevent high blood-sugar. It was developed by Janssen Pharmaceuticals and approved by the FDA in 2013. It was the first drug in a new class known as sodium-glucose cotransporter-2 (SGLT2) inhibitors.
Side Effects of Invokana
Invokana is a diuretic, and its most common side effect is urinating more often. This significantly increases a patient’s risk of urinary tract infections (6% of patients) and vaginal yeast infections (10% of women). The following severe side effects have been linked to Invokana:
- Bone fractures
- Diabetic ketoacidosis
- Metabolic acidosis
- Heart attack
- Kidney failure
- Urinary tract infections
Invokana and Ketoacidosis
In clinical trials, patients on Invokana were significantly more likely to develop ketoacidosis than patients on other SGLT2 inhibitors. Ketoacidosis normally involves very high blood-sugar levels. However, many Invokana patients with normal or mildly-elevated blood-sugar have developed ketocidosis. The unusual symptoms can delay diagnosis and treatment until it becomes life-threatening.
What is Ketoacidosis?
Diabetic ketoacidosis is a medical emergency that occurs when toxic wastes known as ketones build up in the bloodstream. The condition usually occurs when the body does not have enough insulin to use glucose (sugar) as a source of energy. Instead, it starts burning fat cells, which releases ketones into the bloodstream. High levels of ketones in the body can cause diabetic coma (passing out for a long time) or even death.
Symptoms of Diabetic Ketoacidosis
- Nausea and vomiting
- Stomach pain
- Tiredness or decreased alertness
- Deep, rapid breathing
- Dry skin and mouth
- Flushed face
- Frequent urination or thirst that lasts a day or more
- Fruity-smelling breath
- Muscle stiffness or aches
FDA Safety Warnings for Ketoacidosis
May 15, 2015 — FDA issues a Safety Communication for all SGLT2 inhibitors, including Invokana, after receiving 20 reports of patients who developed diabetic ketoacidosis from March 2013 to June 2014.
December 4, 2015 — The FDA updated the label on Invokana to include ketoacidosis. The agency received 73 reports of patients who were hospitalized with ketoacidosis between March 2013 and May 2015, but many more cases were likely never reported.
“Patients should stop taking their SGLT2 inhibitor 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. Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing.”
Invokana and T1 Diabetes Linked to 5-10% Risk of Ketone Problems
Invokana is not approved for people with type-1 diabetes, but it is sometimes used “off-label” to help them control blood-sugar levels. In April 2016, a study published in Diabetes Care found that 5-10% of people with type-1 diabetes who take insulin and Invokana developed ketone-related adverse events, including severe ketoacidosis that required hospitalization. Click here to read more.
Over 100 Cases of Ketoacidosis Reported Worldwide
In June 2015, European health officials warned that SLGT2 inhibitors were associated with 101 cases of diabetic ketoacidosis worldwide as of May 19. All of the cases were serious and some patients had to be hospitalized. Six months later, the consumer advocacy group Public Citizen warned that the FDA had received over 168 reports of ketoacidosis in patients on Invokana who developed metabolic acidosis (too much acid in the body).
Other Risk-Factors for Ketoacidosis
Australian health officials warn that in some cases, just before ketoacidosis occurred, the patient had an acute illness (such as, urinary tract infection, urosepsis, gastroenteritis, influenza, trauma or surgery), reduced caloric or fluid intake, and/or reduced insulin dose.
Urinary Infections and Kidney Failure
Invokana works by helping the kidneys remove excess sugar through the urine. Because it relies so heavily on the kidneys, many experts are warning about side effects like kidney failure and infections.
Between March 2013 and October 2014, the FDA received 19 reports of patients on SGLT2 inhibitors who developed life-threatening complications of urinary tract infections, such as blood infections (urosepsis) and kidney infections (pyelonephritis)
The FDA recommends that patients on Invokana should seek medical attention if they develop symptoms of a urinary infection, such as:
- Burning sensation when urinating
- Frequent and urgent urination
- Pain in the lower part of the stomach or pelvis
- Blood in the urine
Common Medications Increase Risk of Kidney Injury
Risk-factors for acute kidney injury include dehydration, decreased blood volume, chronic kidney insufficiency, congestive heart failure. Medications like diuretics, blood pressure drugs (ARBs and ACE inhibitors), and NSAID painkillers like ibuprofen also increase the risk of kidney injury.
Heart Attack & Stroke Risk Information
In clinical trials, 13 patients on Invokana had a heart attack or stroke during the first 30 days of treatment, compared to just one patient on a placebo. The risk normalized after 30 days. Data from the CANVAS clinical trial linked Invokana to a 46% increased risk of stroke, but only in the first 30 days.
When the FDA approved Invokana in March 2013, they asked Janssen to conduct more studies. According to the New York Times:
“The label of the drug includes no warnings about heart attacks or strokes. … The FDA is requiring Johnson & Johnson to conduct five post-marketing studies, including a clinical trial to determine more definitively if the drug increases those risks.”
Has Invokana been recalled? No, Invokana has not been recalled. However, Janssen is currently studying many severe side effects and a recall may be necessary if studies find evidence of deadly risks.
Has a lawsuit been filed? Yes, the first lawsuits were filed in December 2015 by plaintiffs who were diagnosed with ketoacidosis after taking Invokana. Click here to read more.
How long do I have to file a lawsuit? Every state has its own laws regarding the “statute of limitations,” which is a time-limit to file a lawsuit. It can be as short as one year from the time of your diagnosis, so talk to an attorney as soon as you think you have a claim. More answers to frequently asked questions.
Invokana Class Action
Our lawyers are nationally-recognized class action attorneys, but we are not filing a class action lawsuit at this time. Instead, we are filing individual lawsuits against Janssen Pharmaceuticals on behalf of people who were injured by the most serious side effects of Invokana.
Do I have an Invokana Lawsuit?
The Schmidt Firm, PLLC is currently accepting Invokana induced injury cases in all 50 states. If you or somebody you know was diagnosed with diabetic ketoacidosis or kidney failure, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
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