This article contains frequently asked questions and answers about Invokana, a type-2 diabetes drug that has been linked to diabetic ketoacidosis, amputations, kidney failure, heart problems, and other severe side effects.
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 ketoacidosis, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
What is Invokana?
Invokana is the brand-name of canagliflozin, a new treatment for type-2 diabetes made by Janssen Pharmaceuticals, a unit of Johnson & Johnson. When it was approved on March 29, 2013, Invokana was the first drug in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors.
How Does Invokana Work?
Invokana relies heavily on the kidneys to work. It helps the kidneys excrete extra glucose in urine, which lowers blood-sugar levels and helps prevent hyperglycemia.
What Side Effects Should I Expect?
Invokana is a diuretic and the most common side effect is increased urination. This can lead to other problems like urinary tract infections or vaginal yeast infections. In some cases, patients lose too much fluid and experience dizziness, fainting, or low blood-pressure when standing up.
What Are Severe Side Effects of Invokana?
- Diabetic ketoacidosis (too much acid in the blood)
- Heart attack
- Kidney failure
- Kidney infections (pyelonephritis)
- Bone fractures
- Kidney stones
- Urinary tract infections (UTIs)
- Blood infections (urosepsis)
- Allergic reactions
What FDA Warnings Have Been Issued?
Amputations: The FDA opened an investigation in May 2016 after studies showed that 7 in 1,000 patients on Invokana needed a foot, toe, or lower leg amputation, which was about twice the risk of patients who did not take Invokana. The agency required drug-makers to add a “Black Box” warning label about the risk of amputations in May 2017.
Diabetic Ketoacidosis: The FDA issued a Safety Communication about this risk in May 2015 and updated warning labels seven months later. At least 73 severe cases of ketoacidosis were reported from March 2013 through May 2015.
Bone Fractures: Taking Invokana for as little as 12 weeks can decrease bone mineral density and increase your risk of bone fractures after minor trauma, according to a warning from the FDA in September 2015.
Kidney and Urinary Infections: From March 2013 through October 2014, the FDA received 19 reports of blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections. Some patients needed intensive care or dialysis for kidney failure.
Why Is Ketoacidosis from Invokana Unusual?
Ketoacidosis can occur in patients on Invokana who have normal blood-sugar levels or only moderate hyperglycemia. This is unusual because ketoacidosis is normally associated with type-1 diabetes and very high blood-sugar. These unusual symptoms may delay diagnosis and treatment.
Does Invokana Have Higher Risks?
Invokana increases your risk of ketoacidosis more than other SGLT2 inhibitors, and higher doses are associated with higher risks, according to clinical trial data reviewed by the American Diabetes Association.
Are There Risk-Factors for Ketoacidosis?
In some reports, ketoacidosis occurred at the same time or just after a patient had a urinary tract infection, urosepsis, gastroenteritis, influenza, trauma or surgery, reduced caloric or fluid intake, and/or reduced insulin dose, according to warnings from Australian health officials.
Has a Recall Been Issued?
No. Invokana has not been recalled, but it may be recalled in the future if studies find evidence of deadly side effects. For example, Janssen is investigating the risk of heart attack and stroke after clinical trials showed elevated risks in the first 30 days of treatment.
Have Lawsuits Been Filed?
Yes, the first lawsuit (Case No. 15-12-00653) was filed in Philadelphia in December 2015 by a man who developed ketoacidosis after taking Invokana. Lawyers are concerned that Janssen Pharmaceuticals may have inadequately warned about side effects.
Has a Class Action Been Filed?
An Invokana class action has not been filed, and it is unlikely that people with severe injuries would join this type of lawsuit. Our attorneys are filing individual lawsuits instead of a class action. If many lawsuits are filed, they may be consolidated at the state or federal level.
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.