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The FDA-approved type 2 diabetes medication Invokana (canagliflozin) first came on the market in March 2013. Now, only a little over two years later, the medication has been linked to a number of dangerous side effects, including kidney failure, diabetic ketoacidosis, bone fractures, and more.

A recent report by the Institute for Safe Medication Practices (ISMP) questioned the widespread use of the medication, stating: “The unanswered question about canagliflozin…is whether it has clinical benefits, and whether those benefits outweigh its risks.”

FDA Concerned Even at Time of Invokana’s Approval

Though the FDA approved Invokana for lowering blood glucose levels in type 2 diabetes patients, they expressed some concerns at the time. The clinical trials the manufacturer, Janssen Pharmaceuticals, submitted for review showed a potential risk for cardiovascular issues, bone health problems, liver abnormalities, and health risks in children. The FDA required Janssen to conduct additional studies on the drug to further evaluate Invokana’s safety profile in these areas.

The ISMP’s initial concerns were based on its review of data from Invokana’s first year on the market, which showed 457 reports of adverse events, including kidney stones, kidney impairment or failure, urinary tract infections, dehydration and other fluid imbalances, and hypersensitivity. When questioned about these reports, Janssen responded that the warning label already contained information about these risks, with the exception of kidney stones. In addressing them, the company claimed there was insufficient information to assess any potential links between the drug and kidney stones.

FDA Warns About Invokana Diabetic Ketoacidosis

In May 2015, the FDA warned about another serious side effect that had not been included on the drug’s labeling: diabetic ketoacidosis (DKA). This is a condition in which a person’s blood becomes too acidic. Without treatment, it can lead to coma and even death.

The FDA noted in their safety communication that they had already received 20 reports of type 2 diabetes patients who were taking Invokana hospitalized for this condition between 2013 and 2014, with additional reports received after the closing date. These reports caught their attention because patients with type 2 diabetes don’t often develop DKA—it’s a condition that more frequently affects type 1 diabetes patients.

The FDA warned doctors and patients to watch out for symptoms of DKA, including difficulty breathing, unusual fatigue, and nausea and vomiting.

FDA Warns About Invokana Bone Fractures

Just a few months later, in September 2015, the FDA issued yet another safety communication concerning Invokana. This time, they noted that they had required the manufacturer to strengthen the warning on the drug’s label about bone fractures.

This is one of the side effects the FDA was concerned about at the time of approval. Two years later, additional studies have shown that bone fractures can occur as early as 12 weeks after starting Invokana, and that the drug has also been linked to decreases in bone mineral density at the hip and lower spine. The FDA advised doctors to consider a patient’s other potential risk factors for bone problems before prescribing Invokana.

A recent Invokana class action lawsuit filed in Canada raises additional concerns about the drug’s potential to cause kidney injuries. The plaintiffs claim the warnings are not adequate, and are demanding compensation for kidney problems like kidney impairment and kidney failure.

One Comment

  1. Gravatar for Audrey

    If someone's liver doesn't work, we blame it on the genes; if someone's brain doesn't work properly, we blame the school. It's actually more humane to think of the condition as genetic. For instance, you don't want to say that someone is born unpleasant, but sometimes that might be true.

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