A new class of Type 2 diabetes treatments, which includes the popular drug Invokana, has been linked to a serious condition of too much acid in the blood, known as ketoacidosis.

Invokana, which contains the drug ingredient canagliflozin, was approved by the Food and Drug Administration (FDA) in March 2012. It is classified as an SGLT2 inhibitor, which works by reducing blood sugar levels by helping the patient’s kidney’s remove excess sugar through their urine. Other drugs in this class include the brand names Invokamet, Farxiga, Xigduo XR, Jardiance, and Glyxambi.

In May 2015, the FDA issued a warning that SGLT2 inhibitors had been linked to ketoacidosis, a serious buildup of acids, called ketones, in the blood that can be life threatening if left untreated. The condition is caused by an insulin deficiency that forces cells to burn fat for energy instead of glucose, which produces ketones. In diabetic patients, it is also known as diabetic ketoacidosis, or DKA. At that time, the FDA reported 20 cases of ketoacidosis in patients who had used SGLT2 inhibitors.

The following month, the European Medicines Agency (EMA) announced that it had launched a safety review of all three SGLT2 inhibitors marketed in Europe after receiving reports of 101 cases of DKA in patients worldwide who had used the drugs. In most instances, patients had taken the drug for two weeks or less before developing symptoms. Almost all had to be hospitalized.

Since then, the FDA has launched its own investigation to determine if the safety concerns warrant adding stronger warnings to the labels of all SGLT2 inhibitors.

Symptoms of DKA include difficulty breathing, nausea and vomiting, abdominal pain, confusion, unusual fatigue or sleepiness, diabetic coma and death.

Attorneys with Beasley Allen Law Firm are currently investigating cases of ketoacidosis or DKA in patients who have taken Invokana or another SGLT2 inhibitor.

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