Diabetes Drug Invokana Linked to Kidney Failure and Impairment

The treatment of diabetes is among the most common drug therapies in the U.S., and 21 million Americans took blood sugar lowering drugs in 2012, with more than 90 percent of those being treated for Type 2 diabetes.

The U.S. Food and Drug Administration (FDA) approved Invokana in March of 2013 as the first drug in a new class of oral agents to lower blood sugar in patients with Type 2 diabetes. Invokana, which is marketed by Janssen Pharmaceuticals, works by inhibiting the normal function of the kidney, which is to return any glucose to the blood circulation while excreting other unwanted substances. Instead, Invokana causes substantial amounts of sugar to be excreted in the urine.

Invokana Adverse Event Reports

During the first year after Invokana’s approval, the drug was prescribed over 426,000 times, according to Institute for Safe Medication Practices (ISMP) data, but 457 serious adverse events were also identified, with five different adverse effects related directly or indirectly to renal toxicity, including kidney failure or impairment, dehydration, fluid imbalances, kidney stones, urinary tract infections, and abnormal weight loss. The FDA Adverse Event Report System found at least 20 cases discovered between March 2013 and June 2014 where type-2 diabetes patients developed some form of ketoacidosis.

Do the Benefits of Invokana Outweigh the Risks?

The ongoing question about Invokana deals with whether the drug’s clinical benefits outweigh its risks, mainly kidney impairment and failure. At the time of FDA approval, Invokana had not been tested on a sufficient number of patients over a time period sufficient to answer that question, although higher dose animal studies with uncertain applicability to human exposure showed long-term kidney damage, kidney and testicular cancers, and bone abnormalities with long-term Invokana use.