Invokana Amputation Lawsuits
There has been a continued growing number of lawsuits that are claiming that Jassen Pharmaceuticals, a subsidiary of Johnson & Johnson, failed to warn consumers about life-threatening side effects of Invonkana (Canagliflozin.) The Type 2 diabetes drug has been linked to kidney damage, ketoacidosis, infections, bone fractures, toe amputations, heart attacks and even stroke.
The highly anticipated United States release of Invokana, a new drug for type-2 diabetes could not come quickly enough for the medical community and healthcare investors. According to the press, the drug would usher in a “revolution” in blood sugar management, with an active ingredient from a newly-designed drug class that operates by modifying kidney function. With over 29 million Americans currently suffering from the disease of diabetes, it is a growing health problem in the United States. Of the newly diagnosed cases of diabetes in adults, approximately 95% are for Type-2 diabetes (sometimes referred to as adult onset). It’s also expected that one out of every three people will develop diabetes in their lifetimes. From the perspective of pharmaceutical companies, there was a huge, open market as well as a true need for an effective Type-2 diabetes drug. In March of 2013, the FDA approved the drug Invokana (Canagliflozin) and Janssen, a subsidiary of Johnson & Johnson filled the market gap and claimed to have met the needs of patients as millions of dollars rolled in.
What Can You Do and How Can Jones Brown PLLC Help?
The Law Offices of Jones Brown PLLC is currently accepting Invokana induced injury cases in all 50 states. If you or a loved one was diagnosed with a severe side effect, you should contact our professional and experienced team of attorneys immediately for a free case consultation. Please CLICK HERE and fill out our free online defective drug questionnaire or call us toll-free at 855-525-2999.
Invokana Drug Facts
Canagliflozin (trade name Invokana or Sulisent) is a medication used for the treatment of type 2 diabetes. It is of the gliflozin class or subtype 2 sodium-glucose transport (SGLT-2) inhibitors class. This mechanism is associated with a low risk of hypoglycemia (too low blood glucose) compared to sulfonylurea derivatives and insulin. In 2017, the FDA concluded that canagliflozin causes an increased risk of leg and foot amputations. The FDA began requiring a Boxed Warning to be added to the canagliflozin drug labels to describe this risk.
What is the Problem with Invokana?
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. 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 (Diabetic ketoacidosis is an acute metabolic complication of diabetes characterized by hyperglycemia, hyperketonemia, and metabolic acidosis.
Possible Side Effects of Invokana:
- Bone Density Issues and Fractures
- Metabolic Acidosis
- Diabetic Ketoacidosis
- Heart Attacks
- Urosepsis – Blood Infections
- Kidney Failure
- Pyelonephritis – Kidney Infections
- Urinary Tract Infections
FDA Safety Warnings for Ketoacidosis:
The FDA issued a safety warning in May of 2015 for all SGLT2 inhibitors including Invokana, after the administration received 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 FDA received 73 reports of patients who were hospitalized suffering from ketoacidosis between March 2013 and May 2015.
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.
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 and attorneys are claiming these warnings are inadequate because they do not specifically address the risk of kidney failure or the extent of the risk associated with Invokana.
Invokana and Urinary and Kidney Infections:
To put it simply, Invokana works by helping the kidneys remove the body’s excess sugar from a persons urine. It is because of this process that many experts are warning about side effects like kidney infections and failure are possible. 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).
Invokana and Heart Attack and Stroke Risk:
When conducted, clinical trials found 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.
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.
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
- Stomach Pain
- Nausea and Vomiting
- Deep, Rapid Breathing
- Tiredness or Decreased Alertness
- Dry Skin and Mouth
- Fruity-Smelling Breath
- Flushed Face
- Frequent Urination or Thirst
- A Headache
- Muscle Stiffness or Achiness
Do You Have an Invokana Lawsuit?
The Law Office of Jones Brown PLLC is currently accepting Invokana induced injury cases in all 50 states. If you or a loved one was diagnosed with Diabetic Ketoacidosis or Kidney Failure you should contact our professional and experienced defective drug attorneys immediately for a free case consultation. Please CLICK HERE to fill out our Jones Brown PLLC’s Defective Drug Questionnaire or contact us 24 hours a day at 855-525-2999 or 918-947-9555.
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