The U.S. Food & Drug Administration (FDA) continues to receive adverse event reports involving SGLT2 inhibitors, such as Invokana, and diabetic ketoacidosis. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine.
According to the most recent QuarterWatch report issued by the Institute for Safe Medication Practices (ISMP), the agency’s adverse event database received 168 such reports involving Invokana during the 12-month period ending June 30, 2015. During the same time period, the database logged 80 cases involving Farxiga and 12 reports associated with Jardiance. The ISMP was unable to estimate the incidence of ketoacidosis among patients using Invokana, Farxiga or Jardiance, as it is not known how many cases go unreported.
“In the past year, the FDA has issued two safety alerts regarding ketoacidosis and SGLT2 inhibitiors. Our Firm has since received a number of inquiries from patients who allegedly suffered this serious complication while using one of these medications to treat Type 2 diabetes. We are not surprised that the FDA continues to receive these types of reports,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices.
SGLT2 Inhibitor and Diabetic Ketoacidosis
Invokana, Jardiance, Farxiga and other SGLT2 inhibitors are approved to lower blood sugar in patients with Type 2 diabetes. In May 2015, the FDA announced that it was investigating 20 reports of diabetic ketoacidosis that had occurred in individuals taking SGLT2 inhibitors. While some patients had been using the medications to treat Type 1 diabetes (an off-label use), a number of the ketoacidosis reports involved patients undergoing treatment for Type 2 diabetes. While ketoacidosis is often associated with Type 1 diabetes, it is unusual in patient with Type 2.
On December 4th, the FDA announced that new information regarding a potential association with diabetic ketoacidosis would be included on the labels for Invokana and other SGLT2 inhibitors. The alert indicated that from March 2013 to May 2015, the FDA had identified 73 cases of ketoacidosis in patients with Type 1 or Type 2 diabetes treated with SGLT2 inhibitors.
Diabetic ketoacidosis occurs when dangerous levels of toxic acids called ketone accumulate in the body. The condition can lead to hospitalization, diabetic coma and even death. “Patients should stop taking their SGLT2 inhibitor and seek medical attention immediately if they have any symptoms of ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones. Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing,” the FDA said in its December 4th communication.
Patients who used Invokana or another SGLT2 inhbitor may be entitled to compensation if they were hospitalized with ketoacidosis while undergoing treatment.