FDA Issues Invokana Side Effects Safety Communication

The FDA issued a safety communication on May 15 warning of serious Invokana side effects involving ketoacidosis, a condition in which too much of certain kinds of acid (ketones) are found in the blood. The agency noted that several instances of the condition, resulting in hospitalization or emergency room visits, had been reported in connection to the use of the drug Invokana (or canagliflozin, manufactured by Jannsen Pharmaceuticals, a subsidiary of Johnson & Johnson). Invokana is used to treat type 2 diabetes.

According to their statement, the FDA received 20 reports of ketoacidosis between March 2013 to June 6, 2014, and continued to receive subsequent reports after the latter date. The condition usually strikes patients with type 1 diabetes but has cropped up in connection to patients being treated for type 2 diabetes with the drug Invokana, the first of the so-called SGLT2 inhibitors to be approved.

FDA warns of Invokana side effects

The FDA warns that patients taking Invokana should be on the lookout for the following symptoms of ketoacidosis: “difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.” Patients experiencing such symptoms should seek medical treatment immediately. If not treated, the condition can lead to loss of consciousness, coma, and ultimately death.

Health care professionals should treat patients with these symptoms by evaluating for possible acidosis or ketoacidosis, correcting the acid imbalance condition and monitoring sugar levels. SGLT2 inhibitor medications should be discontinued; however, patients are warned not to stop or change medications without first being evaluated by the professional prescribing them.

Other SGLT2 inhibitors are Farxiga (dapagliflozin) and Jardiance (empagliflozin). The three drugs also are marketed in combination with other drugs as Invokamet (canagliflozin and metformin), Xigduo XR (dapagliflozin and metformin extended-release), and Glyxambi (empagliflozin and linagliptin). The FDA says that the will continue to monitor and investigate the situation.

Janssen releases results of Invokana studies

Three days after the FDA announcement, manufacturer Janssen Pharmaceuticals 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.

Invokana was approved by the FDA in March of 2013. Its mechanism for treating diabetes 2 differ 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. In addition to holding out promise for effective diabetes treatment, Invokana may also help to lower excess weight. However, the drug has been linked not only to ketoacidosis, but also to kidney and heart problems.

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