Pharmaceutical

Invokana warnings updated to include ketoacidosis risk

Invokana 149x210 Invokana warnings updated to include ketoacidosis riskThe safety label of the type 2 diabetes drug Invokana (canagliflozin) and others in its class have been updated to include a new warning for ketoacidosis, a serious life-threatening condition in which too much acid builds up in the blood causing complications such as difficulty breathing, nausea and vomiting, abdominal pain, confusion, unusual fatigue, diabetic coma and death.

Invokana was approved by the Food and Drug Administration (FDA) in March 2013, becoming the first SGLT2 inhibitor to hit the market. It is manufactured by Johnson & Johnson subsidiary Janssen Pharmaceuticals.

In May, the FDA ordered makers of SGLT2 inhibitors to add the new warning for ketoacidosis after receiving 20 reports of the condition in patients who used the drug from March 2013 to June 6, 2014. All patients required emergency room visits or hospitalization to treat their condition. The agency said that since June 2014, it continued to receive reports of ketoacidosis in patients treated with the drugs.

The brand name SGLT2 inhibitors with the new ketoacidosis risk warnings include:

  • Farxiga (dapagliflozin) Tablets
  • Glyxambi (empagliflozin and linagliptin) Tablets
  • Invokana (canagliflozin) Tablets
  • Invokamet (canagliflozin and metformin HCl) Tablets
  • Jardiance (empagliflozin) Tablets
  • Synjardy (empagliflozin and metformin hydrochloride) Tablets
  • Xigduo XR (dapagliflozin and metformin HCl extended release) Tablets

“Patients treated with this product who present with signs and symptoms consistent with severe metabolic acidosis should be assessed for ketoacidosis regardless of blood glucose levels as ketoacidsosis associated with this product may be present even if blood glucose levels are less than 250 mg/dL. If ketoacidosis is suspected, this product should be discontinued, the patient should be evaluated and prompt treatment should be instituted. Treatment of ketoacidosis may require insulin, fluid and carbohydrate replacement,” the new warning states.

Warnings for serious urinary tract infections including urosepsis and pyelonephritis have also been added to the safety labels of all SGLT2 inhibitors. Some users of these medications who suffered urinary tract infections required hospitalization, the warning states.

Attorneys with Beasley Allen Law Firm are currently investigating cases of ketoacidosis in patients who used Invokana and other SGLT2 inhibitors.

Source: FDA