One of the newest type-2 diabetes drugs, Invokana, has already been associated with life-threatening side effects like amputations, ketoacidosis, kidney failure, infections, bone fractures, and more.
Need a Texas Invokana Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with a severe side effect, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
UPDATE: Invokana Doubles Ketoacidosis Risk, Study Finds
Invokana doubles the risk of ketoacidosis compared to diabetes drugs in the DPP-4 inhibitor class, according to a study published in the New England Journal of Medicine in June 2017. An estimated 5 to 8 patients per 1,000 starting Invokana will develop ketoacidosis, a life-threatening condition involving too much acid in the blood. Click here to read more.
Invokana Lawsuits Centralized in New Jersey
In December 2016, judges centralized nearly 100 lawsuits involving ketoacidosis, kidney failure, and other side effects of Invokana into Multi-District Litigation (MDL No. 2750) in the U.S. District Court for New Jersey under Judge Brian R. Martinotti. Lawyers requested the same venue in September.
What is Invokana?
Invokana (canagliflozin) is a prescription medication for the treatment of type-2 diabetes. It is made by Johnson & Johnson’s Janssen Pharmaceuticals unit and was approved by the FDA in March 2013.
How Does It Work?
Invokana relies on the kidneys to work. It stops the kidneys from re-absorbing glucose and helps the kidneys excrete more glucose in urine. When it was approved in 2013, Invokana was the first drug in a new class of diabetes medications known as sodium-glucose cotransporter-2 (SGLT2) inhibitors.
FDA Issues Ketoacidosis Warnings
In May 2015, the FDA issued a Safety Warning about the risk of diabetic ketoacidosis from Invokana. The next month, over 100 cases were reported by the European Medicines Agency (EMA). In December 2015, the FDA updated the label on Invokana to include ketoacidosis. Invokana patients may have normal or only mildly-elevated blood-sugar levels when they develop this side effect. The unusual symptoms may delay diagnosis or treatment, which could lead to complications like coma or death.
FDA Strengthens Kidney Injury Warnings
In June 2016, the FDA issued a Safety Warning about the risk of acute kidney injury from Invokana. The agency has received over 100 confirmed reports. Risk-factors include common medications like diuretics, blood pressure drugs (ARBs and ACE inhibitors), and painkillers like ibuprofen. Click here to read more.
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.
Invokana ‘Black Box’ Warning for Amputation Risk
In May 2017, the FDA ordered drug-makers to add a “Black Box” warning label about amputations. The warnings were issued after data from two large clinical trials (CANVAS and CANVAS-R) concluded that patients on Invokana were twice as likely to require a foot, toe, or leg amputation compared to patients who were not on Invokana. According to the FDA:
“Amputations of the toe and middle foot were most common, but amputations of the leg below and above the knee also occurred. Some patients had multiple amputations, or both legs amputated.”
Side Effects of Invokana
Invokana is a diuretic that causes patients to urinate more frequently, which helps reduce blood-sugar levels. The most common side effects are urinary tract infections (6% of patients) and vaginal yeast infections (10% of women). Patients on Invokana have also experienced severe side effects, such as:
- Allergic reactions
- Blood infections (urosepsis)
- Bone fractures
- Diabetic ketoacidosis (too much acid in the blood)
- Heart attack
- Kidney failure
- Kidney infections (pyelonephritis)
- Kidney stones
- Metabolic acidosis
- Urinary tract infections (UTIs)
What is Ketoacidosis?
Diabetic ketoacidosis (ketosis) occurs when the body is unable to use sugar (glucose) in the bloodstream as a fuel source, and must instead break down fat cells. When fat cells break down, acidic waste products called ketones build up in the blood and urine. Symptoms may include:
- 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
- Nausea and vomiting
- Stomach pain
Invokana and Type-1 Diabetes
The FDA has not approved Invokana for type-1 diabetes, but doctors sometimes prescribe it “off-label” to improve blood-sugar control. In April 2016, Diabetes Care published a study linking the use of Invokana (canagliflozin) with an increased risk of diabetic ketoacidosis (DKA). Ketone-related adverse events occurred in 5-10% of type-1 diabetic patients on 100-mg or 300-mg doses in addition to insulin. Click here to read more.
Has Invokana been recalled? No, but it is possible a recall will be issued in the future if Invokana is linked to a deadly side effect. Janssen is currently investigating the risk of heart attack and stroke.
Have lawsuits been filed? Yes, a man who developed ketoacidosis after taking Invokana filed the first lawsuit on December 10, 2015 in the Philadelphia Court of Common Pleas. The plaintiff took Invokana for only three months before he was diagnosed with ketoacidosis. Click here to read more.
How much time do I have to file a lawsuit? Every state has its own deadline to file a lawsuit called a “statute of limitations.” It can be as little as one year from the time of your diagnosis, so talk to a lawyer as soon as you think you have a case. Click here for more frequently asked questions.
Invokana Class Action Lawsuit
The Clark Firm, LLP is nationally recognized as a class action law firm in Texas, but our attorneys are not currently filing an Invokana class action. Instead, we are filing individual lawsuits against Janssen Pharmaceuticals and only accepting cases involving severe injuries.
Need an Invokana Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas Invokana lawyers for a free lawsuit review.