In June 2016, the FDA strengthened its prior warnings about the diabetes medication Invokana, advising in a safety announcement that patients who had taken Invokana should seek medical attention immediately at the first sign of an acute kidney injury, or AKI.
The new advisory came after the agency had already issued multiple warnings the previous year that Invokana was causing ketoacidosis and urinary tract problems, some of which required hospitalization.
In acute kidney injury, the kidneys suddenly cease working, creating unsafe levels of wastes to build up in the body. Signs and symptoms include decreased urine or swelling in the legs or feet.
The agency urged patients taking Invokana and other similar diabetes medications to be vigilant and consult a medical professional at the first sign of trouble. “Patients should not stop taking their medicine without first talking to their health care professionals. Doing so can lead to uncontrolled blood sugar levels that can be harmful,” the FDA cautioned.
The blockbuster anti-diabetes medication Invokana, created by Johnson & Johnson’s Janssen Pharmaceuticals, was first approved by the FDA in 2013. Since then it has been linked to multiple cases of kidney failure and diabetic ketoacidosis. At the height of its popularity, the drug was pulling in over $1 billion a year for the company.
Invokana belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors, which also includes Invokamet, Farxiga, and Xigduo XR. Each of these medications is specifically cited in the FDA’s most recent warning.
The June 2016 advisory followed three prior warnings released over the course of the previous year. The first, in May 2015, appeared after the agency received 20 serious adverse event reports of severe diabetic ketoacidosis, which required hospitalization occurring in patients who had taken Invokana or similar medications. In October, the agency required that Invokana’s manufacturer add information about the potential for bone fracture due to decreasing bone density in elderly patients.
In December of last year, the FDA increased the urgency of the original ketoacidosis warning, noting that the agency had received an additional 53 ketoacidosis reports for a total of 73 serious ketoacidosis occurrences requiring hospitalization.
In addition to the increased number of ketoacidosis reports, the FDA stated that they have received notification of 19 severe urinary tract infection events of urosepsis or pyelonephritis which required hospitalization. Some of these patients experienced kidney failure and required dialysis.
As of February 2017, there were over 150 product liability actions against Johnson & Johnson stemming from damage to kidneys caused by Invokana.