Invokana was first approved by the U.S. Food and Drug Administration (FDA) in March 2013. It’s manufactured and marketed by Janssen Pharmaceuticals, Inc., and was Initially hailed as a “miracle drug” for the treatment of Type 2 diabetes.
Since that time, the medication has been linked to numerous injuries, including kidney failure, ketoacidosis, leg and foot amputations, and heart attacks.
Invokana (canagliflozin) is part of the gliflozin class of drugs. Other prescription drugs in this class currently approved in the U.S. include Farxiga (dapagliflozin) and Jardiance (empagliflozin). These medications act to inhibit the reabsorption of glucose in the kidneys, thereby lowering a patient's glucose levels.
The mechanism of action of these drugs is to inhibit sodium-glucose transport protein 2 (SGLT2), which is involved in the reabsorption of glucose in the kidneys. For this reason, these drugs are also known as SGLT2 inhibitors. Essentially, excess glucose is eliminated and passed in the urine.
Invokana differs from its competitors by inhibiting the action of SGLT1, which causes glucose to remain in the intestinal tract, making it more effective in controlling blood sugar levels.
Additional benefits of Invokana that have been touted include:
- once daily dosage
- no weight gain
- lowering of blood pressure
- minimal risk of hypoglycemia (excessively low blood sugar)
Invokana and Heart Issues
Invokana was first introduced in January 2013 at a meeting of the FDA Endocrinologic and Metabolic Drugs Advisory Committee (EMDA). Representatives of Janssen Pharmaceuticals gave a number of presentations on the growing prevalence of Type 2 diabetes among the world's population and the increasing need for effective treatments.
These presentations were essentially opportunities to promote the new medication. However, one attendee raised serious questions. Dr. Sydney Wolfe noted that Janssen's request for FDA approval was “based solely on surrogate efficacy of HbA1c lowering,” a measure of a patient's glucose control.
At the time, Dr. Wolfe said: “As with all recently approved Type 2 diabetic drugs, [there is] no evidence of any improved clinical outcomes, contrary to an older diabetes drug such as metformin . . . this surrogate efficacy needs to be balanced against a number of serious safety signals identified in the clinical trials.”
Dr. Wolfe's concerns were centered around the danger of blood clotting, which can put a patient at risk for a heart attack. Thirteen subjects who participated in Invokana's clinical trials experienced such “cardiovascular events.” Dr. Wolfe noted that gliflozin drugs in general were associated with a dangerous increase in the concentration of red blood cells, or hematocrit levels. By extrapolating data from a study of Farxiga, he found that patients taking Invokana would experience an elevation in hematocrit levels of as much as 50% greater than those taking Farxiga.
Wolfe was not the only one at the meeting to express concerns. FDA Reviewer Dr. Hyon Kwon noted an “imbalance in early cardiovascular events” during the clinical trial. Another FDA adviser, Dr. Mat Soukop, pointed out that patients who took Invokana were almost seven times as likely to suffer heart attacks than those who were given placebos.
Despite Dr. Wolfe's expert testimony and the agency's own biostatistical analysis, the FDA determined that the potential benefits of Invokana outweighed the risks. Approval was granted for the drug on the condition that Janssen monitor the product for adverse events and conduct a “post-market” double-blind study over the next four years.
Invokana and Ketoacidosis, Kidney and Renal Issues
Since the time Invokana was granted FDA approval, numerous watchdog organizations, such as the Institute for Safe Medication Practices (ISMP), have pointed out that Invokana did not undergo sufficient testing during the clinical trials.
Just over a year after Invokana's approval, the ISPM issued a report on data indicating a link between kidney damage and renal failure and SGLT2 inhibitors. The following year, the FDA issued a warning that Invokana and similar SGLT2 inhibitors can cause a serious condition known as ketoacidosis. When this happens, the patient's blood becomes dangerously acidic, leading to symptoms that include:
- respiratory distress
- nausea and vomiting
- abdominal pain
- mental confusion and disorientation
- abnormal fatigue and narcolepsy
Significantly, diabetic ketoacidosis (DKA), while not unusual in Type 1 diabetics (insulin dependent childhood-onset), is rare with Type 2 (insulin-resistant adult-onset) diabetes. It should be noted that SGLT2 inhibitors and other diabetic medications are ineffective in controlling Type 1 diabetes and are not meant for that purpose.
Invokana and Cancer, Pancreatitis, Osteoporosis & Amputation Issues
Additional dangers that have been associated with Invokana include an increased risk of:
- breast and bladder cancer
- inflammation of the pancreas (pancreatitis)
- yeast infections
Most recently, the final results from two clinical studies (CANVAS and CANVAS-R) demonstrated a definite link between Invokana and an elevated risk of lower limb amputations. Since May 2017, the FDA has required Invokana packaging in the U.S. to carry a “black box” warning to that effect, advising doctors to discontinue Invokana for patients who experience unusual pain, sores or infections in the extremities.
As of August 2017, there were no fewer than 800 lawsuits pending against Johnson & Johnson and Janssen involving Invokana. Plaintiffs attorneys argue that these companies failed to warned doctors and patients that Invokana increased the risk of a patient experiencing kidney failure, ketoacidosis, leg and foot amputations, and heart attacks.
For extensive information on these court proceeds, visit our Invokana Lawsuit Page. This page describes in detail the litigation pending against Johnson & Johnson and Janssen, and how someone injured by Invokana can participate in the court proceedings and receive compensation for their injuries.