The FDA issued a safety communication in May 2015 regarding SGLT-2 inhibitor drugs such as Invokana, and the next month Health Canada began an investigation into the safety of SGLT-2 inhibitors. Like the FDA, Health Canada was concerned with the potential of Invokana and other SGLT-2 drugs such as Farxiga, Jardiance, Invokamet, Xigduo XR and Glyxambi to cause potentially fatal diabetic ketoacidosis.
Health Canada noted that while diabetic ketoacidosis most commonly develops in those with Type 1 (juvenile) diabetes, more and more cases of ketoacidosis were turning up in those with Type 2 diabetes who were taking SGLT-2 inhibitor drugs. Because diabetic ketoacidosis is rare among those with Type 2 diabetes, the fear is that the condition will not be identified and treated quickly enough.
FDA Receives Significant Number of Invokana Adverse Event Reports
After reviewing their own database of adverse events, Health Canada expects to determine whether changes in prescribing information are needed on Invokana and other SGLT-2 inhibitors. The FDA issued their warnings after receiving more than 20 reports regarding patients with Type 2 diabetes taking SGLT-2 drugs who were hospitalized with diabetic ketoacidosis. The patients who developed this serious disease initially had only very slightly elevated blood sugar levels, making it crucial to provide information to patients regarding the risks of ketoacidosis when taking SGLT-2 drugs.
All told, within a year of Invokana’s FDA approval, more than 450 adverse event reports had been submitted to the agency. Most of those reports were related to serious, even fatal conditions associated with the drug. The most serious issues associated with Invokana are ketoacidosis, kidney failure and kidney disease, and serious cardiovascular events such as heart attack, blood clots and stroke.
Diabetic Ketoacidosis Caused by Invokana
Ketoacidosis can result to swelling of the brain, extreme dehydration, coma and death. When high levels of blood acids, also known as ketones, build up in a patient’s blood after the body loses its ability to produce sufficient insulin, ketoacidosis can occur. SGLT-2 inhibitors like Invokana do not metabolize insulin in the same way older diabetic drugs like metformin do. SGLT-2 drugs target the kidneys, increasing the excretion of sugar through the urine, and stopping the sugars from be reabsorbed into the kidneys.
Many consider this an unnatural process for the kidneys; when insufficient insulin is available to the body, it begins burning fat as an energy source, building up blood acids in the process. Type 2 diabetics taking Invokana should be alert for symptoms of ketoacidosis such as: dry mouth, frequent urination, excessive thirst, fruity-smelling breath, stiff muscles, nausea, unusual aches and pains, decreased alertness, rapid breathing, dry skin and vomiting lasting more than two hours. Potential complications from diabetic ketoacidosis can be the death of bowel tissue, kidney failure and heart attack.
Did Janssen and Johnson & Johnson Fail to Warn Consumers?
The question arises as to whether the potentially dangerous side effects of Invokana were not adequately communicated by the manufacturer to consumers. In other words, in the interests of larger quarterly earnings, did J & J and Janssen deliberately fail to warn patients of potential hazards associated with Invokana? If failure to warn is found to be present, manufacturers may be held liable for consumer injuries. The manufacturers of Invokana were surely aware of the hundreds of adverse event reports associated with their drug.
A National Center for Biotechnical Information (NCBI) article noted Invokana had the same adverse effects as dapagliflozin, due to the similar way both drugs work work, and that the drugs could lead to arterial hypotension, altered renal function, dehydration and urogenital infections. In conclusion, the NCBI article noted an unfavorable harm-benefit balance, stating Invokana should not be used in the treatment of Type 2 diabetes. This clear warning could make it difficult for J & J and Janssen to claim they were unaware of the risks associated with Invokana, making them responsible for failure to warn.