What is Invokana?
Invokana is a type 2 diabetes drug also known Canagliflozin. It was developed by Mitsubishi Tanabe Pharma and is marketed under a license by Janssen, a division of Johnson & Johnson. Type 2 diabetes is the most common form of the disease, affecting about 24 million people and accounting for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.
How Does it Work?
Invokana is an inhibitor of subtype 2 sodium-glucose transport protein (SGLT2), which is responsible for at least 90% of the renal glucose reabsorption (SGLT1 being responsible for the remaining 10%). Blocking this transporter causes up to 119 grams of blood glucose per day to be eliminated through the urine, corresponding to 476 kilocalories. Additional water is eliminated by osmotic diuresis, resulting in a lowering of blood pressure.
According to the FDA, its safety and effectiveness were evaluated in nine clinical trials involving over 10,285 patients with type 2 diabetes. The initial clinical trials showed improvement in hemoglobin A1c levels (a measure of blood sugar control) and fasting plasma glucose (blood sugar) levels.
Other SGLT2 inhibitors include:
- Xigduo XR
When Was it Put on the Market?
Invokana became the first SGLT2 inhibitor to be approved in the United States. As a condition of approval, the FDA is requiring five postmarketing studies for Invokana: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study.
What are the Minor Side Effects?
Common minor side effects of Invokana are vaginal yeast infection, urinary tract infection, sudden dizziness and fainting.
Major Problems Discovered
1. FDA Warning Letter. On May 15, 2015, the FDA issued a Safety Communication warning consumers that SGLT2 inhibitors such as Invokana may result in a dangerous condition called ketoacidosis. Ketoacidosis is a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.
The FDA searched the Adverse Event Reporting System (FAERS) database and identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014 in which the consumer was hospitalized. The FDA is going to follow the drug for further study.
2. Institute for Safe Medicine Practices. According to a report from the Institute for Safe Medication Practices (ISMP), Invokana has been linked to hundreds of severe adverse events. ISMP claims it counted over 457 adverse events for Invokana in its first 12 months on the market, including:
- Kidney failure or damage
- Kidney stones
- Fluid/electrolyte problems
- Urinary tract infections
Janssen claims that its product already providing warnings about the possibility of kidney failure. The ISMP report questions whether the benefits of the drug outweigh the risks. Invokana’s label currently warns of the possibility for “impairment of renal function,” but does not address kidney failure specifically.
What to do if You Have Experienced Kidney Failure or Diabetic Ketoacidosis After Taking Invokana
Ashcraft & Gerel is still investigating whether they will pursue litigation against the makers of Invokana. If you believe you have been injured, however, please contact us. We may be able to assist you in the future or answer any questions you may have. Contact as at 703-931-5500.