It’s not enough that the type 2 diabetes drug is a blockbuster, nabbing more than $1 billion in sales in 2015 despite a growing list of side effects. Its makers, Johnson & Johnson and subsidiary Janssen Pharmaceuticals, hope to draw users by promoting the drug as a tool to help reduce cardiac events.
Later this year, Johnson & Johnson and Janssen will be armed with results from a seven-year study called CANVAS looking at the drug’s impact on the heart health of about 4,300 patients. If that data is favorable, the companies will likely ask the Food and Drug Administration (FDA) if they can expand the indication to include that information, which will appear as a coup to some.
But patients beware. The list of Invokana side effects is growing at an alarming rate.
Invokana was approved by the FDA in 2013 as the first drug in a class of diabetes medications known as SGLT2 inhibitors. The drugs work by lowering blood sugar levels by metabolizing excess sugar through the kidneys and excreting it through the urine. This novel process resulted in genital and urinary tract infections, which patients were alerted to at the time of the drug’s approval.
Since then, the FDA has strengthened or added various new warnings to the safety label of Invokana (canagliflozin) and its combination drug Invokamet (canagliflozin and metformin). Those warnings include an increased risk of bone fractures and decreases in bone mineral density, and increased risk of serious urinary tract infections, acute kidney injury, lower limb amputations, and ketoacidosis, a condition in which too much acid builds up in the blood.
Last month, the U.S. Judiciary Panel on Multidistrict Litigation consolidated dozens of Invokana side effects lawsuits in federal court against Johnson & Johnson and Janssen involving claims that the drug companies failed to warn consumers of potential serious risks.