Product News and Recalls

FDA Adds Ketoacidosis, Urinary Infection Warnings to SGLT2 Inhibitor Labels

fda adds additional warnings to SGLT2 inhibitor labelsThe U.S. Food and Drug Administration (FDA) has revealed in a new safety communication that the labels of sodium-glucose cotransporter-2 (SGLT2) inhibitors will now carry warnings about ketoacidosis and serious urinary infections. The update comes after a communication earlier this year in which the FDA warned SGLT2 inhibitors may lead to diabetic ketoacidosis, a serious condition caused by too much acid in the blood.

Up until now, SGLT2 inhibitors have been marketed as a safer, more effective alternative to older diabetes treatments. But new information from the FDA may make patients and doctors more cautious about Invokana and other SGLT2 inhibitors. From March 2013 to May 2015, the FDA found 73 instances of ketoacidosis in SGLT2 users on its adverse event reporting system, all of which required hospitalization or treatment in an emergency department.

In addition to potentially causing diabetic ketoacidosis, SGLT2 inhibitors may make it more difficult to diagnose the condition. The FDA’s data appear to confirm this problem. According to the agency, “in many cases, ketoacidosis was not immediately recognized because the blood glucose levels were below those typically expected for diabetic ketoacidosis. As a result, treatment of the ketoacidosis was delayed in some cases.”

The FDA also ”identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections” between March 2013 and October 2014. All 19 patients required hospitalization.

In light of these reports, the FDA is now requiring manufactures of SGLT2 inhibitors like Invokana to include ketoacidosis and urinary infection warnings on their drugs’ labels. Additionally, the agency has requested that manufacturers like AbbVie and Eli Lilly conduct a five-year postmarket study to evaluate SGLT2 inhibitors’ link to ketoacidosis.

You should speak to your doctor about any medical concerns you may have. If you or a loved one was diagnosed with diabetic ketoacidosis or a serious blood infection after using a SGLT2 inhibitor such as Invokana, contact the lawyers at Lopez McHugh to receive a free legal consultation. We can help you determine whether an SGLT2 inhibitor lawsuit is right for you.