Invokana (canagliflozin) was introduced by Johnson & Johnson in March 2013 and has rapidly grown to become a blockbuster treatment for type-2 diabetes amid aggressive marketing.

However, it now appears that the drug maker may have withheld important information about the potential risks users may face from Invokana side effects.

Invokana Problems

Invokana was the first member of a new class of diabetes medications introduced in the United States, known as sodium-glucose co-transporter 2 (SGLT2) inhibitors.

The medication works by inhibiting some kidney functions to increase the amount of sugar excreted in the urine. This was designed to increase glucose production and lower blood glucose levels among diabetics.

During the first year the diabetic medication was on the market, hundreds of reports involving Invokana problems were submitted to the U.S. Food and Drug Administration (FDA) with reports of:

• Kidney failure
• Kidney impairment
• Kidney stones
• Urinary tract infections
• Abnormal weight loss
• Hypersensitivity reactions

Invokana’s mechanism for treating diabetes differs from older medications in that it causes the kidneys to pass large amounts of glucose (sugar) directly through the urine. Older drugs tend to affect the amount or functioning of insulin. However, the drug has been linked not only to kidney problems but also to ketoacidosis.

What is Keotacidosis?

Ketoacidosis is a medical condition where high levels of ketones are produced in the body. Ketoacidosis can result in a patient suffering from a diabetic coma, extended hospitalization and even death.

Ketoacidosis develops when the body is unable to produce enough insulin, which plays a major role in helping sugar (glucose) enter cells, and provides needed energy to the muscles and other tissues.

Without enough insulin, the body breaks down fat as an alternative source of energy, which produces a buildup of toxic acids in the bloodstream called ketones. Excess ketones result in ketoacidosis if untreated.

FDA Warns of Invokana Side Effects

In a recent drug safety announcement, the FDA said it was investigating reports that certain type-2 diabetes drugs caused ketoacidosis. The FDA’s investigation reportedly came after the agency reviewed 20 adverse event reports from patients who were seriously injured or hospitalized for the condition after taking type-2 diabetes medications, including Invokana and Invokamet.

The agency indicated that patients should be made aware of a potential link between Invokana and ketoacidosis, and the importance of seeking immediate medical attention, if they experience symptoms such as:

• Difficulty breathing
• Nausea
• Vomiting
• Abdominal pain
• Confusion
• Unusual fatigue or sleepiness

J&J Releases Invokana Studies

Three days after the FDA announcement, Johnson & Johnson announced the results of three “real world analyses” of blood sugar levels in patients taking Invokana.

Their main findings were that once-daily doses of Invokana for adults with type-2 diabetes resulted in significant improvements in blood glucose (A1C) levels for those patients and that those results held true even when patients stopped taking other blood-sugar-lowering medications that they had been using simultaneously.

The study results were presented at the 20th Annual Meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in Philadelphia. The meeting took place between May 16 and 20 and included 15 separate presentations on the drug Invokana.