New research suggests that patients who take Invokana and other SGLT2 inhibitors to control Type 2 diabetes may be more likely to develop diabetic ketoacidosis compared to those using other treatments. Scientists at Boston’s Brigham and Women’s Hospital are now advising doctors to monitor these patients closely, as ketoacidosis can prove deadly if not recognized and treated immediately.
Ketoacidosis is usually observed in patients with Type 1 diabetes. But this new study, published June 8th in the New England Journal of Medicine, confirms that the disorder can also occur in Type 2 diabetics who take SGLT2 inhibitors, a class of medications that includes Invokana, Invokamet, Farxiga, Xigduo XR, Jardiance and Glyxambi.
In reaching their conclusions, the authors of the report analyzed data from 40,000 Type 2 diabetics. Those taking SGLT2 inhibitors where twice as likely to develop diabetic ketoacidosis compared to those taking another class of medications called DPP4 inhibitors. However, the researchers stressed that the overall risk remains low, as only about 1 in every 1,000 patients would develop ketoacidosis.
“This is a side effect that’s usually seen in patients with Type 1 diabetes mellitus — not Type 2 — so doctors are not ‘on the lookout’ for it,” Dr. Michael Fralick, an author on the study and member Brigham and Women’s division of pharmacoepidemiology and pharmacoeconomics, said in a statement announcing the findings. “That means that the risk of this side effect might actually be even higher than what we found due to misdiagnosis/under-recording.”
Diabetic ketoacidosis results from a dangerous accumulation of toxic blood acids called ketones. Symptoms of the disorder include vomiting, abdominal pain, shortness of breath and swelling in the brain. Left untreated, diabetic ketoacidosis can quickly progress to diabetic coma and even death.
In December 2015, the U.S. Food & Drug Administration (FDA) ordered the manufacturers of Invokana and other SGLT2 inhibitors to add new information to their product labels regarding a potential risk of diabetic ketoacidosis. The agency acted after a review of its adverse event database uncovered 73 reports of ketoacidosis that had occurred among individuals treated with SGLT2 inhibitors. The FDA advised patients to stop taking their SGLT2 inhibitor and seek medical attention immediately if they develop any symptoms of the disorder.
Hundreds of lawsuits have been filed in U.S. courts on behalf of individuals who suffered ketoacidosis, kidney injuries and other side effects allegedly related to treatment with SGLT2 inhibitors. Federally-filed Invokana lawsuits are undergoing centralized pretrial proceedings in a multidistrict litigation now underway in in the U.S. District Court, District of New Jersey. Lawsuits involving Farxiga have been consolidated in the U.S. District Court, Southern District of New York.