Invokana: Do the Benefits Really Outweigh the Risks?

Invokana, the first SGLT-2 inhibitor approved by the U.S. Food and Drug Administration (FDA) to treat type 2 diabetes, caused concerns about cardiovascular injuries and kidney failure early on, within two years of the drug’s introduction to the market in 2013.

Invokana is prescribed to treat type 2 diabetes by blocking the reabsorption of glucose of the kidneys, impacting normal kidney function and allowing more sugar to be passed from the body through urine. Since approval, the drug has been linked to not only to an increased risk for heart problems, but also to the development of diabetic ketoacidosis (DKA), a dangerous buildup of ketones in the bloodstream that can lead to diabetic coma and even death.

It has been reported that prior to FDA approval in March 2013, concerns had already been raised about Invokana and the potential for heart problems, kidney failure, and risk to bone health associated with the drug. The FDA’s policy has traditionally been to consider a drug worthy of approval if the benefits associated with it are higher than the risks, suggesting that the agency determined that Invokana’s benefit to those suffering from Type 2 diabetes outweighed the risks, which include:

• Cardiovascular issues
• Kidney failure
• Kidney impairment
• Kidney stones
• Urinary tract infections (UTIs)
• Dehydration
• Hypersensitivity
• Abnormal weight loss

These serious side effects have led some patients and medical professionals to wonder why a medication would be approved with this level of risk potential. As a result, health advocates are beginning to speculate as to whether Invokana was properly researched prior to FDA approval, and whether the risks of the diabetes drug might actually outweigh the benefits after all.

According to data from the Centers for Disease Control and Prevention, 29.1 million Americans suffer from type 1 or type 2 diabetes, the bulk suffering from type 2, which affects an estimated 26 million Americans alone.