The most serious side effect associated with Invokana, and the focus of a growing number of lawsuits against the drug and its manufactures, is ketoacidosis.
Ketoacidosis is a medical condition that occurs when the body produces too many acids called ketones (chemicals that break down fat). This happens when your cells do not get enough glucose for energy production, and thus, the body will begin to burn fat for energy instead, increasing production of ketones. Ketoacidosis is a serious medical condition that can lead to a coma or even death. The signs and symptoms of this condition develop rapidly, usually within 24 hours.
Diabetic ketoacidosis is usually seen with insulin deficiency, hyperglycemia, and dehydration. It is more common with those patients who are type 1 diabetics, than type 2 diabetics, which is atypical. Those patients that have reported with ketoacidosis who were type 2 diabetics only had moderate increases in blood sugar, when normally patients with ketoacidosis had dangerously high blood sugar levels.
The FDA even warned in a Safety Communication in May of 2015 that SGLT2 inhibitors, which Invokana is, can cause diabetic ketoacidosis. Additionally, according to the Institute for Safe Medication Practices, during the first year after Invokana was released on the market, there were over 450 adverse event reports filed with the FDA, including:
- 54 reports of kidney failure or impairment
- 54 cases of dehydration or fluid imbalance
- 11 cases of kidney stones
- 50 cases or urinary tract infections
- 52 cases of abnormal weight loss
- 50 cases of hypersensitivity (rapid swelling of the tongue, lips, throat, face)
However, the most serious adverse event reported is ketoacidosis, which between March 2013 and June 2014 the FDA’s Adverse Event Reporting System database identified at least 20 incidents of diabetic ketoacidosis in patients who were taking SGLT2 inhibitors.
Symptoms of Diabetic Ketoacidosis may include:
- Increased urination
- Increased thirst
- GI disturbance (pain, nausea)
- Fatigue
- Weakness
- Shortness of breath
- Breath which smells “fruity”
Advanced Symptoms may include:
- Vomiting
- Trouble breathing
- Confusion, Dizziness or Fainting
- Unconsciousness
If you experience any of these symptoms, seek medical attention immediately.