Invokana Kidney Failure Lawsuit Information
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- 1 Invokana Kidney Failure Lawsuit Information
Popular Diabetes Medication Invokana Linked to Ketoacidosis, Bone Fractures, and Kidney Injury
Invokana, canagliflozin, is prescribed to millions of patients across the globe, earning drug maker Johnson & Johnson about $1.3 billion in 2015. Despite how popular the medication is, patients are suffering serious adverse events, including ketoacidosis, bone fractures, and kidney injury.
Within two years of being approved for the U.S. market as a treatment for Type 2 Diabetes, the U.S. Food and Drug Administration began logging serious adverse events in patients who were prescribed the medication. These adverse events include potentially fatal side effects.
If you or a family member were prescribed Invokana and suffered ketoacidosis or kidney failure, this guide will help you learn more about the drug, side effects, and the actions of the FDA regarding this drug. This guide will also help you explore the options that may be available to you.
Important Warning Video
What is Invokana?
Canagliflozin sold under the brand name Invokana is a daily diabetes medication that belongs to a new generation class of medications called SGLT2 inhibitors. Invokana is manufactured by Janssen Pharmaceuticals, a subsidiary of drug giant Johnson & Johnson.
SGLT2 inhibitors block the transportation of sodium-glucose to lower blood sugar levels by allowing the kidneys to excrete higher levels of glucose from the body. Invokana was approved for this use by the FDA in 2013 for Type 2 diabetes, and not long after, other SGLT2 inhibitors followed, including
|SGLT2 Inhibitor||Brand Name|
|Combination drug canagliflozin and metformin||Invokamet|
|Combination drug linagliptin and empagliflozin||Glyxambi|
|Extended release combination drug metformin and dapagliflozin||Xigduo XR|
Within two years of being approved for the U.S. market, the FDA issued a warning that Invokana increased the risk of developing a deadly condition called ketoacidosis created by too much acid in the blood. Diabetic ketoacidosis is a potentially fatal condition in which the body uses fat instead of sugar for energy. As the body breaks down fat, acidic ketones begin to build up and become toxic, causing malfunction of internal organs. Ketoacidosis can lead to coma and death.
In May 2015, the FDA issued a drug safety communication warning of the association between SGLT2 users and ketoacidosis. The FDA reported 73 known cases of diabetic ketoacidosis (DKA). In many of these cases, the patient’s blood glucose levels were lower than physicians normally see with DKA which caused diagnosis and proper treatment to be delayed. The agency acknowledged that their data only includes reports submitted to the FAERS, so it is likely that there are more unknown cases of patients developing ketoacidosis.
According to the FDA Safety Announcement, patients using Invokana and other SGLT2 inhibitors should stop using the medication and seek immediate medical attention if they experience any of the symptoms of ketoacidosis –
- A change in body odor or sweat
- A metallic or sweet taste in the mouth or on the breath
- Difficulty breathing or shortness of breath
- Excessive thirst
- Fast and deep breathing
- Fatigue and malaise, or unusual tiredness
- Rapid weight loss
- Stomach and abdominal pain
The FDA required all SGLT2 inhibitor manufacturers to conduct a postmarketing follow-up study to collect additional information regarding patients on these drugs and the development of ketoacidosis. Manufacturers were to update the Warning and Precautions labels of all SGLT2 medications to include the increased risk of ketoacidosis.
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Linked to Kidney Failure
The FDA issued another warning in December 2015 alerting consumers and the medical community about Invokana urinary tract infections that progressed to blood infections (urosepsis) and kidney infections (pyelonephritis) that begin as urinary tract infections. The FDA had received at least 19 reports of life-threatening urosepsis and pyelonephritis that required hospitalization. Several of the patients were treated with dialysis or admitted to an intensive care unit to treat kidney failure.
In May 2016, the FDA strengthened the kidney warning for users of Invokana. The agency said that by October 2015 it had received 101 cases of acute kidney injury, though there are likely more cases, and some of these patients had to be hospitalized and receive dialysis. The FDA noted that nearly half of these patients developed acute kidney injury within the first 30 days of starting the medication.
Any patient who experiences decreased urination or swelling of the legs and feet while taking Invokana should seek medical attention immediately as this condition can quickly lead to a dangerous buildup of waste levels in the body.
As a patient, it’s important that you be aware of the symptoms of a urinary tract infection and seek medical attention immediately if you experience them.
- Bloody urine
- Burning sensation when urinating
- Feeling that you need to urinate right away
- Needing to urinate often
- Pain in the pelvis or lower abdominal area
Be aware of the symptoms of blood infection, including –
- Fever and chills
- Nausea and vomiting
- Rapid breathing
- Rapid pulse
- Very low body temperature
Other Serious Side Efects
Invokana has also been linked to decreased bone density and fractures that can occur from simply tripping or falling from standing height. The FDA updated the Warning and Precaution label to include that that bone fractures occur more frequently in patients using an SGLT2 inhibitor like Invokana and that they can occur after as little as 12 weeks after beginning treatment with Invokana.
The FDA also required new safety information to be added to the Adverse Reaction section of the medication label warning that Invokana causes loss of bone mineral density at the lower spine and hip. This information was added in September 2015 after the results of an FDA required clinical trial showed Invokana caused greater bone loss than placebo.
Invokana is also currently under investigation for a potential link to increased amputations. This investigation stems from the results of an ongoing Canagliflozin Cardiovascular Assessment Study (CANVAS) clinical trial that should be completed in 2017. The study has noted higher rates of leg, toe and foot amputations on patients taking Invokana. Per the FDA, amputations are twice as high in Invokana users than non-users.
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How We Can Help
Our attorneys are fierce advocates for people harmed by dangerous drugs that offer no real benefit over similar drugs without potentially fatal side effects. If you or a family member has suffered a serious side-effect from Invokana or another SGLT2 inhibitor, you have rights under the law. We defend those rights and help you seek maximum compensation for your injuries.
We Fight To Get You The Justice Deserved
Texas native Attorney Adam Pulaski has spent decades fighting for the rights of persons harmed by the negligence of others. Representing clients in all 50 states, Adam uses his experience and knowledge to advocate for those harmed by the negligence of others and has resolved thousands of cases by relentlessly pursuing his cause using any means available through the court system.
Adam successfully negotiated the premier national round II opt-out Fen-Phen Diet Drug Litigation settlements. He was instrumental in facilitating the recall of over 4 million Bumbo baby seats and continues to represent the families of infants who suffered skull fractures and other serious injuries from these dangerous products.
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