Lawsuits against Invokana, a Type-2 diabetes inhibitor medication, have begun to surface as patients across the United States are reporting serious and life-threatening side effects that weren’t warned about. These early lawsuits may set the stage for many more future suits as the case of Invokana’s risks become further documented. Read on for a brief history of Invokana, its reported side effects, and current cases.
What is Invokana?
Invokana (canagliflozin), produced by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, is an SGLT2-class diabetic inhibitor that is designed to block glucose (a sugar compound found in blood) from being reabsorbed in the kidneys and instead expelled from the body through urination. People diagnosed with Type-2 diabetes tend to have higher glucose levels which, when combined with their low insulin count, neglects the health of body cells and can cause severe issues with the kidneys, heart, nerves, or eyes.
The U.S. Food and Drug Administration (FDA) approved Invokana on March 29, 2013, for sale and distribution on the medical market. Invokana was the first of its diabetic inhibitor class to receive FDA approval, but according to a report, it had not recorded sufficient patient testing data to measure its benefits against the risks described in a growing number of complaints before being approved.
In response to the concerns surrounding the drug, the FDA issued an alert in May 2015 and updated in December about the dangers of SGLT2 inhibitors, and another alert specifically for Invokana in September 2015 about complications with bone density and fracturing.
What are Invokana’s side effects?
Patients and medical practitioners have reported the following side effects, some of which have manifested in as soon as 24 hours following the initial dosage:
- Diabetic Ketoacidosis
- Bone fracturing
- Decrease in bone mineral density in the lower extremities, including the hips and lower spine
- Kidney damage and failure
- Genital yeast infection
- Hyperkalemia (high potassium levels in the blood)
- High cholesterol
- Urinary tract infection
- Increased urgency for urination, especially in frequency, volume, or at night
Diabetic Ketoacidosis (DKA) is currently the most serious and common of the reported highlighted in lawsuits. DKA occurs when the human body’s cells are deprived of glucose and begins to burn fat for energy using acids called ketones. When an inhibitor like Invokana forces a diabetic’s body to expel the glucose it needs, the resulting ketone buildup makes blood acidic which poisons the body and can lead to a diabetic coma or death.
Usually DKA is rare in Type-2 diabetics, but Invokana and other SGLT2 inhibitors are now known to facilitate the condition. The FDA warns patients to stop taking Invokana and to seek immediate medical attention if they exhibit any DKA symptoms, including:
- trouble breathing
- abdominal pain
Possible urinary tract infection symptoms should also be monitored, including:
- blood in urine
- abdominal or pelvic pain
- an urge to urinate often or immediately
- a burning sensation during urination
Within the first year of its FDA approval, Invokana had sold nearly 427,000 outpatient prescriptions, which was considered a significant success by Janssen and the Institute for Safe Medication Practices. However, 457 reports were filed at that time concerning a number of side effects, including kidney failure or damage and urinary tract infections. Since then, there have been over 70 reports of DKA in patients taking Invokana.
Invokana lawsuits in the U.S. surfaced as recently as October 2015 from states including Illinois, Texas, Alabama, and Louisiana. Each victim shares a similar story: they were all prescribed Invokana to treat their diabetes and only learned about the risks of the medication’s true side effects after being diagnosed with and suffering from DKA.
These individual cases and future ones will likely, eventually, be united under an MDL to address their similar allegations that Janssen knowingly put consumers at risk without informing medical practitioners or producing warning labels with the medication addressing the severity of the risks. It may be years before these cases are resolved as lawsuits against Invokana and Janssen are just starting to take form.
In the meantime, it will be worth watching the Invokana situation continue to develop. So far the FDA has only issued public warnings about the medication’s dangers, but as more affected consumers take to the courts, the big question of whether the FDA will take action to restrict Invokana’s sales or wholly remove it from the market will be on everyone’s minds.
What should I do if I’ve suffered from using Invokana?
Help is available! If you were prescribed Invokana to treat your diabetes and weren’t warned of the severity of these alleged side effects by the medication’s labeling or your prescribing doctor, you most likely have a case you can take to court. To understand the extent of your rights and the options available to you in your area, contact a personal injury attorney today and have your case reviewed.