A growing number of lawsuits accuse Janssen Pharmaceuticals of failing to warn about life-threatening side effects of Invokana. This new diabetes drug has been linked to ketoacidosis, kidney damage, infections, bone fractures, toe amputations, heart attacks, and stroke.
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.
UPDATE: Invokana Linked to Genital Infections
In August 2018, the FDA issued a Safety Communication after 1 person died and 11 others were hospitalized with a severe genital infection called necrotizing fasciitis of the perineum (Fournier’s gangrene) after taking diabetes drugs in the SGLT2 inhibitor class.
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.
What is the problem?
Invokana helps treat diabetes by forcing the kidneys to remove more sugar (glucose) from the body in urine. This is why the most common side effect is urinating more often. Excessive urination can cause mineral deficiencies, which may be why Invokana increases the risk of bone fractures.
Severe Side Effects of Invokana
- Bone fractures
- Diabetic ketoacidosis
- Fournier’s gangrene (necrotizing fasciitis of the perineum)
- Metabolic acidosis
- Heart attack
- Kidney failure
- Urinary tract infections
FDA Safety Warning for Ketoacidosis
In May 2015, the FDA issued a Safety Warning for all SGLT2 inhibitors, including Invokana, after receiving 20 reports of patients who developed diabetic ketoacidosis from March 2013 to June 2014. In December 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.
Invokana Doubles Ketoacidosis Risk, Study Finds
In June 2017, a study in the New England Journal of Medicine found that Invokana doubles the risk of diabetic ketoacidosis (DKS) compared to diabetes medications in the DPP-4 inhibitor class. The estimated risk of DKA is 5 to 8 patients per 1,000 who start taking Invokana or other diabetes drugs in the SGLT2 inhibitor class. Click here to read more.
Infection Risks of Invokana
Invokana also increases the amount of sugar in urine, which significantly increases a patient’s risk of urinary tract infections (6% of patients) and vaginal yeast infections (10% of women). In some cases, these infections spread to the bloodstream or kidneys and become life-threatening. Infections and dehydration are also risk-factors for ketoacidosis and metabolic acidosis.
Invokana and 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. In May 2017, the FDA confirmed the risk and ordered drug-makers to add a “Black Box” warning label about amputations.
Invokana and Kidney Failure
In June 2016, the FDA strengthened warnings about sudden kidney injuries from Invokana, which can cause kidney failure. The agency received 101 confirmed cases of acute kidney injury from March 2013, when Invokana was approved, until October 2015.
The label on Invokana merely indicates that “kidney problems” are a “possible side effect” of Invokana. 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. Here are a few examples:
- March 2015 — Lawsuit (PDF) filed in Delaware by a woman who was diagnosed with kidney failure.
- February 2016 — Lawsuit (PDF) was filed in California by a woman who was hospitalized with kidney failure in March 2015.
- February 2016 — Lawsuit (PDF) filed in Kentucky by a woman who was hospitalized with kidney failure in February 2015.
- December 2015 — Lawsuit (PDF) filed in Tennessee by a man who started taking Invokana in November 2013 and developed kidney failure.
Urinary & Kidney Infections
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)
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 2013, they did not require warning labels about cardiovascular events. Instead, they asked Janssen to conduct 5 post-marketing studies to determine if Invokana increases these risks, according to the New York Times.
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.
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.
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
Over 100 Cases of Ketoacidosis Reported
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).
Invokana and T1 Diabetes
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.
Invokana Lawsuits Centralized in New Jersey MDL
In December 2016, a panel of federal judges centralized nearly 100 lawsuits involving side effects of Invokana and Invokamet into a Multi-District Litigation (MDL No. 2750). The litigation will be coordinated in the U.S. District Court for New Jersey under Judge Brian R. Martinotti — the same venue lawyers requested in a motion filed in September.
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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