Invokana was introduced to the U.S. market in March 2013 and quickly became the go-to type 2 diabetes treatment, although the safety of the medication became a point of contention relatively quickly.
What is Invokana?
Invokana is a SGLT2 inhibitor that is prescribed along with diet and exercise to help improve glycemic control and lower blood sugar in adult patients with type 2 diabetes mellitus. If left untreated, type 2 diabetes can lead to a number of serious health problems, including:
- Nerve damage
- Kidney failure
- Heart disease
- High blood pressure
In May 2015, the FDA warned the public that canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance) may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization and could lead to death. The FDA warned patients to pay close attention for signs of Ketoacidosis and to seek medical attention if they experienced any signs.
Symptoms of Diabetic Ketoacidosis Include
- Difficulty Breathing
- Abdominal Pain
- Unusual Fatigue
Following the warning issued in May 2015, the FDA reviewed the FDA Adverse Event Reporting System and identified 73 cases of ketoacidosis in patients with type 1 or type 2 diabetes. As a result, the FDA followed up with a label change for Invokana, Farxiga and Jardiance in December 2015 which noted the risk of ketoacidosis.
In addition to diabetic ketoacidosis, there are several other serious and even potentially fatal side effects associated with Invokana, Farxiga and Jardiance, including:
- Myocardial infarction (heart attack) – the irreversible death of cells within the heart caused by a restriction of blood.
- Kidney damage and failure – the kidneys stop functioning properly or at all, and waste products, fluids, and electrolytes build up in the body, causing weakness, shortness or breath, lethargy, confusion, abnormal heart rhythm, and sudden death.
Concerns About Safety of Invokana Continue to be Raised
In January 2016, the Institute for Safe Medication Practices released a report that highlighted potential concerns regarding a link between Invokana and kidney damage. According to the report, both prescription volume and adverse drug event reports are increasing rapidly for canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance).
Diabetic Ketoacidosis Lawsuits Move Forward
Lawsuits on behalf of individuals diagnosed with diabetic ketoacidosis continue to be filed against the manufacturers of the drugs, Janssen Pharmaceuticals, AstraZeneca and Boehringer Ingelheim. Plaintiffs allege that they were not warned of the serious risk involved with taking Invokana, Farxiga or Jardiance.