Invokana, a drug approved by the FDA in 2013 for the treatment of Type 2 diabetes (and hailed as the new wonder drug for this form of diabetes) may have a darker side. With little more than two years on the market, more than 450 adverse event reports regarding Invokana have been received by the FDA. Fifty-four of those reports were from patients taking Invokana who experienced renal failure. Other serious issues have also been associated with Invokana, such as ketoacidosis.
What is Ketoacidosis?
Ketoacidosis generally only occurs in those with Type 1, or juvenile diabetes. Those with Type 1 diabetes may develop ketoacidosis from an infection, an injury, a serious illness, surgery or from missing a dose of insulin. Ketoacidosis can be life-threatening, and occurs when the body becomes unable to use glucose (sugar) as a fuel source because of the lack of insulin in the body. When this occurs, fat is used as a fuel source instead of glucose. As the fat in the body breaks down, a waste product known as ketones build up in the blood and the urine.
Ketoacidosis is much less common among patients with Type 2 diabetes, yet some patients taking Invokana have developed this potentially deadly condition. It is believed ketoacidosis can develop in those taking Invokana due to the way in which the drug works. Invokana and other SGLT-2 inhibitors work by preventing the kidneys from reabsorbing glucose back into the bloodstream. This action leads to lower blood glucose levels as the excess blood glucose is eliminated via the kidneys in the patient’s urine.
Some of the symptoms of ketoacidosis include a decreased alertness, dry mouth, dry skin, rapid breathing, frequent urination or excessive thirst lasting for more than a day, a flushed face, fruity-smelling breath, severe headache, stiffness of the muscles, unusual aches, stomach pain, nausea and vomiting. Possible complications from ketoacidosis include fluid buildup in the brain, heart attack, death of bowel tissue and kidney failure.
FDA Warns of Potential Dangers Associated With Invokana and Five Others
On May 15, 2015, the FDA warned that the Type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin, which are all SGLT-2 inhibitors, could cause ketoacidosis. At that time the FDA stated it would continue to investigate this potential safety issue to determine whether changes are needed in the prescribing information for the drugs. The medications targeted by the FDA in this warning are Invokana, Farxiga, Invokamet, Jardiance, Xigduo XR and Glyxambi. Two of those drugs, Invokamet and Xigduo XR combine metformin with the SGLT-2 inhibitor. The FDA database identified twenty cases of ketoacidosis among patients treated with an SGLT-2 inhibitor drug from March 2013 to June 6, 2014. Each of those twenty patients required hospitalization or a trip to the ER to treat the ketoacidosis.
Were Janssen and Johnson & Johnson Aware of the Potential Dangers of Invokana?
Many wonder whether J & J and its subsidiary, Janssen, are guilty of a blatant failure to warn regarding the potential dangers of Invokana. Failure to warn occurs when the manufacturer was aware of potential hazards associated with the drug, yet failed to note those dangers on the labeling which accompanies the drug. A manufacturer can be held liable for this failure to provide adequate warnings if a consumer suffers injury as a direct result of that lack of warning. If failure to warn is claimed in a lawsuit, the plaintiff is required to show the manufacturer was aware of the potential dangers, had a duty to warn consumers and that negligence of that duty caused injury to the plaintiff.
While Johnson & Johnson and Janssen can claim ignorance about the dangers of Invokana, both manufacturers were aware of the adverse reports collected by the FDA. In an NCBI article it was noted that “Canagliflozin (Invokana) has the same adverse effects as dapagliflozin, due to their shared mechanism of action: they include urogenital infections, arterial hypotension, dehydration and altered renal function.” The article concludes that both drugs share an unfavorable harm-benefit balance and should not be used to treat Type 2 diabetes. This failure to warn on the part of Johnson & Johnson and Janssen could be used to prove liability in future lawsuits.