Initially hailed as a “miracle drug” in the treatment of Type 2 diabetes, Invokana is part of a class of drugs known as “gliflozins.” They were designed to control blood sugar levels by preventing the kidneys from reabsorbing glucose so that excess blood sugar could be passed in the urine. Unfortunately, the cure is proving to cause many of the same problems that occur in Type 2 diabetes patients – including kidney failure and nerve damage of the type that leads to amputations.

Before continuing, it is important to understand the difference between Type 1 and Type 2 diabetes. Type 1, also known as “childhood onset,” is a genetic condition in which the patient’s pancreas fails to produce insulin. Essentially, the organ does not function. The only reliable treatment for these patients is for them to take insulin injections on a regular basis.

Type 2 is also known as “adult onset.” While some people are genetically predisposed to this condition, it is largely caused by lifestyle issues, such as obesity, excess consumption of sugar and lack of physical activity. While the pancreas is usually fully functional, the body’s cells have stopped responding to insulin. The condition is known as “insulin resistance.” The standard treatment for the past few decades has been metformin, a relatively harmless medication that prevents the liver from producing as much glucose, in combination with a low-carb diet and exercise. However, in recent decades, the pharmaceutical industry, in part because of a drive to maximize profits and partially in order to cater to people’s desire for quick and easy fixes, has developed a number of medications intended to address the issue of high blood sugar levels.

Gliflozin drugs are the latest attempt to treat the symptoms of Type 2 diabetes. The technical term for this class of drugs is sodium-glucose cotransporter-2, or SGLT-2 inhibitors. One of the side effects of gliflozins is a condition known as ketoacidosis, a condition that lowers blood pH levels, making it highly acidic. This in turn can lead to a kidney infection called pyelonephritis, which can injure the kidneys and cause them to shut down completely. Ironically, this is a common risk for patients with untreated Type 2 diabetes.

Recently, the U.S. Food and Drug Administration has reported that an ongoing clinical trial has found an increased number of patients being treated with Invokana having to undergo foot and leg amputation – yet another risk faced by patients who suffer from chronic high blood sugar levels. Amputations are made necessary because of diabetic neuropathy, or nerve damage, making the patient unaware of injuries and lesions leading to serious infections.

This raises a number of questions. First of all, aren’t these the very conditions Invokana was supposed to prevent? Secondly, how could the manufacturers have been unaware of these dangers before submitting it to the FDA for approval?

In fact, there were concerns raised even before manufacturer Janssen Pharmaceutica even submitted its FDA application. Nonetheless, the FDA went ahead and gave its approval, despite the fact that little was known about possible side effects, and there had been no clinical evidence that Invokana resulted in better outcomes for patients. In the two years following the drug’s approval, there were 73 reports of ketoacidosis – and now, significant numbers of patients requiring amputations. While the FDA has yet to determine a direct link, the concerns have been enough to cause the federal agency to begin an investigation.

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K.J. McElrath is a former history and social studies teacher who has long maintained a keen interest in legal and social issues.