What is Invokana?
Invokana is a Type 2 diabetes medication that contains the active drug ingredient canagliflozin. It belongs to a class of diabetes drugs called sodium-glucose cotransporter 2 (SGLT2) inhibitors. Invokana was approved by the Food and Drug Administration (FDA) in March 2013. It is made by Johnson & Johnson and its subsidiary Janssen Pharmaceuticals.
Invokana is available as a single-ingredient medication and an extended-release formula called Invokana XR. Invokamet is a combination of Invokana and the diabetes drug metformin. Invokana and other SGLT2 inhibitors work by causing excess sugar to be excreted by the kidneys through the urine.
Invokana Side Effects
Invokana has been linked to several serious adverse events:
- Amputations – In May 2014, the FDA informed the public that it was requiring its strongest warning – a boxed warning – be placed on Invokana after the results from two clinical trials – CANVAS and CANVAS-R – showed leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with a placebo.
- Diabetic ketoacidosis (DKA) – In May 2015, the FDA updated the labels of all SGLT2 inhibitors including Invokana with a new warning for ketoacidosis, a condition in which too much acid builds up in the blood. If left untreated, ketoacidosis can lead to diabetic coma and death.
- Kidney injury – In June 2016, the FDA strengthened existing warnings regarding acute kidney injury (AKI) on the labels of Invokana, and two other SGLT2 inhibitors, Farxiga and Xigduo XR. Some cases of AKI in patients treated with these drugs required hospitalization and dialysis. Events of AKI occurred within one moth of starting the drug. And most patients improved after stopping treatment.
- Urinary tract infections leading to kidney and blood infections – In May 2015, the FDA required all SGLT2 inhibitors to update their labels with new warnings regarding urinary tract infections. In some cases, patients with urinary tract infections developed a life-threatening conditions, including blood infections (urosepsis) or kidney infections (pyelonephritis). All patients who developed urosepsis or pyelonephritis were hospitalized and some required intensive care or dialysis due to kidney failure.
- Acute pancreatitis – Invokana has been linked to cases of acute pancreatitis, a painful inflammation of the pancreas.
- Bone fractures – In September 2015, just more than a year after Invokana hit the market, the FDA strengthened the bone fracture warnings on the labels of Invokana, as well as adding information regarding decreased bone mineral density. Fractures occurred as early as 12 weeks after starting treatment.
Invokana Black Box Warning
Reports of Invokana amputations from two clinical trials – CANVAS and CANVAS-R – prompted the FDA in May 2017 to place a black box warning on the labels of Invokana. A black box warning, also called a boxed warning, is the most serious type of warning issued by the FDA. It signifies that use of a certain medical drug or device carries a significant risk of serious or life-threatening adverse effects.
The Invokana boxed warning cautions consumers that the clinical trials indicated that foot and leg amputations occurred about twice as often in people who used Invokana compared to patients treated with a placebo.
Over a year’s time, the CANVAS study showed that the risk of amputation was equivalent to about 5.9 per every 1,000 patients taking Invokana compared to 2.8 per every 1,000 patients treated with a placebo.
Over a year’s time, the CANVAS-R study showed the risk of amputation was 7.5 out of every 1,000 patients treated with Invokana compared to 4.2 out of every 1,000 patients taking a placebo.
The most common amputations among Invokana users were of the toe and middle of the foot. However, there were also reports of amputations involving the leg, both below and above the knee. Some patients had more than one amputation, and some involved both limbs.
More than a thousand people have filed lawsuits in state and federal courts against Johnson & Johnson and Janssen claiming the healthcare giant failed to warn patients and their doctors of serious risks associated with the drug, including amputations, kidney injury and ketoacidosis.
More than 1,000 are consolidated into a multidistrict litigation centralized in the U.S. District Court of New Jersey. The first bellwether trial is scheduled to begin September 2018.
Attorneys with Beasley Allen Law Firm are currently investigating cases of amputations, kidney injury or ketoacidosis in patients who were treated with Invokana, Invokana XR, or Invokamet. If you or a loved one has been injured by Invokana, we would like to talk with you about a possible claim.