Invokana, also known by its trade name canagliflozin is a new drug in the fight against type 2 diabetes, approved for use by the FDA in 2013. With nearly 25 million people suffering from the disease, the demand for new treatments has climbed steadily, pushing pharmaceutical companies into bringing new products to market. While it has shown to aid in controlling the condition, there are some worrying signs that the drug may pose a major threat to some people. In fact, the FDA has informed the drug’s manufacturer, Johnson & Johnson, that it will need to perform at least five post-marketing studies to track any adverse effects that appear in the future. Unfortunately, that data may come at the cost of human lives.

HOW DOES INVOKANA WORK AND WHY IS IT DANGEROUS TO SOME PEOPLE?

Canagliflozin acts on a protein in the body responsible for transporting blood glucose to the kidneys for reabsorption. The drug inhibits this protein, preventing the glucose from being taken back in by the body. Instead, it is excreted through the urine, and the process is so effective it can remove up to 120 grams of blood glucose daily. This keeps blood sugar levels at a manageable level and supports the body’s weakened insulin response.

However, while canagliflozin is unlikely to cause hypoglycemia, compared to other antidiabetic medications, there are significant concerns that the medication may increase the chances of diabetic ketoacidosis onset or various cardiovascular events. Although much research is still to be done, initial studies show a small increase in risk of stroke. This risk appears to be greatest during the first month of treatment, as the rate of cardiovascular events tended to plateau after 30 days.

Diabetic ketoacidosis is the greater concern associated with canagliflozin, as case reports are already demonstrating a marked increase in ketoacidosis prevalence among patients. Diabetic ketoacidosis normally occurs when there is little insulin in the body. This increases the rate at which glucose is released by the liver, which quickly builds up to the point that it filters into the urine. As it is passed, it will leech water, potassium, and sodium, among other elements. The drop in insulin also signals the release of fatty acids, which are converted into ketone bodies.

Ketone bodies are acidic, and with an increasing state of dehydration, blood acid levels spike and result in rapid onset of symptoms. These symptoms include powerful thirst, nausea and vomiting, abdominal pain, and frequent urination. As the condition progresses, confusion, coma, and death are possible. Ketoacidosis is a major medical emergency and should be handled at a hospital immediately. Without treatment, the risk of death is high.

That’s why the FDA already recommends against prescribing Invokana to patients who are at an elevated risk of ketoacidosis already. However, it is unclear just how much higher the risk is with the drug, so patients should keep a close eye on their health if they start taking canagliflozin.