Invokana Lawsuit Information
If you or a loved one were prescribed Invokana for type 2 diabetes and developed a severe urinary tract infection such as pyelonephritis/urosepsis, elevated blood acid, stroke, heart attack or severe kidney disease, you're not alone. Countless lawsuits have already been filed against the manufacturers of Invokana that allege the company failed to properly warn against potentially deadly side effects that users have experienced.
In response to the numerous complaints on record regarding the drug, the FDA investigated and found that Invokana increased the risk of patients developing cardiovascular problems, renal failure, diabetic ketoacidosis and severe urinary tract infections. Had these risks been disclosed to doctors and patients prior to prescribing and/or taking the drug, it is likely another sodium-glucose cotransporter-2 (SGLT2) inhibitor would have been recommended.
SGLT2 inhibitors are a class of drugs designed to lower blood sugar levels in adult patients who suffer from type 2 diabetes.
What Is Invokana?
Invokana, or canagliflozin, is an oral medication developed by Janssen Pharmaceuticals, Inc. to control blood sugar levels in adults diagnosed with type 2 diabetes. The drug helps rid the body of glucose in the bloodstream through the kidneys and is designed to be used in conjunction with a healthy diet and exercise. It is not intended to treat type 1 diabetes.
If left untreated, type 2 diabetes can lead to serious complications, which can include hypoglycemia (dangerously low blood glucose levels) and hyperosmolar hyperglycemic nonketotic syndrome, or HHNS, (dangerously high blood glucose levels) in less severe cases and in more severe cases, diabetic retinopathy (damage to the eyes that in some cases, can lead to blindness), nephropathy (kidney disease), diabetic neuropathy (nerve damage most often occurring in the legs and feet), and macrovascular problems (complications that include coronary artery disease, peripheral arterial disease, and stroke).
None of these conditions should be ignored and each requires safe and monitored treatment for the management and control of type 2 diabetes.
Dangers Associated with the Use of Invokana
In 2013, the makers of Invokana spent $12 million on print advertising to push their product, leading sufferers of type 2 diabetes to believe that this drug provided a simpler way to manage their disease. However, clinical studies of the drug for the purpose of obtaining FDA approval failed to include information regarding safety data and the increased potential for diabetic ketoacidosis.
As a result, people who took Invokana were put at great risk for developing a number of complications that put their greater health in grave danger. According to the FDA's investigation, such conditions include cardiovascular risks, renal effects, diabetic ketoacidosis and severe urinary tract infections.
The FDA reviewer determined early cardiovascular events such as myocardial infarction, better known as a heart attack, were possibly related to hemodynamic changes (which relates to the flow of blood within the body's tissues and organs) after beginning treatment with Invokana. Additionally, eight out of 15 FDA advisory board members expressed deep concern over the cardiovascular results and subsequent risks they posed to patients.
General symptoms of myocardial infarction include:
- Pain that radiates to the jaw, back, arm, or throat
- Pain in the chest resembling a squeezing sensation, pressure, or heaviness
- Difficulty swallowing/choking feeling
- A feeling of fullness or indigestion resembling heartburn
- Excessive sweating, dizziness, nausea and/or vomiting
These are general symptoms, and can vary greatly between men and women.
The FDA reviewer and members of its advisory board also expressed their concerns over the renal effects of taking Invokana experienced by patients, citing the small volume of data related to its safety in relation to kidney problems. As such, the long-term renal effects due to prolonged exposure to the drug remain unknown, which means the true scope of kidney injury to patients could take years to uncover and may be exposed during post-marketing of the drug.
Long-term renal effects include:
- Kidney failure
- Impaired kidney function
As mentioned above, the risk of diabetic keotacidosis (DKA) was not included in the clinical trials or FDA approval process for Invokana, despite data showing a three to one instance of developing DKA while taking the drug as opposed to taking a placebo, leading the FDA to issue a safety alert on May 15, 2015 indicating SGLT2 inhibitors as a class may actually trigger DKA.
Symptoms of diabetic ketoacidosis typically develop quickly, sometimes within 24 hours, and include:
- Shortness of breath
- Abdominal pain
- Nausea and vomiting
- Repeated urination
- Excessive thirst
- Confusion/hazy feeling
- Fruit-scented breath
- Elevated ketone levels in urine
Though the potential for urinary tract infections is listed in the adverse side effects sections of Invokana, it is not listed in the warnings and precautions section despite its prevalence while taking the medication. In fact, the only condition listed in the warnings/precautions setting is genital mycotic infection, commonly referred to as a yeast infection. Severe urinary tract infections carry several health implications and can cause irreparable harm to the kidneys if left untreated.
Such infections include Pyelonephritis/Urosepsis, which is caused by a bacterial infection that has traveled through the bloodstream to the kidneys or spread within the urinary tract to cause inflammation in the pelvis and can lead to a deadly case of sepsis.
Signs of a severe urinary tract infection/pyelonephritis include:
- Blood in the urine
- Cloudy or malodorous urine
- Lower back or side pain
- General malaise
- Nausea and vomiting
- Confusion/hazy feeling
- Urgent need to urinate
- Pain during urination
Don't Wait to Take Action
If you or a loved one took Invokana for the treatment of type 2 diabetes and suffered any of the complications listed above, including death, now is the time to act. How long you have to file a lawsuit, also known as the statute of limitations, is different in every state. If you aren't sure if you can still file a claim, don't worry. We are here for you and will do whatever it takes to help you with your case. We're on your side.