Product News and Recalls

FDA: SGLT2 Inhibitors May Lead to Serious Blood Condition

drug safety warning issued for sglt2 inhibitorsThe U.S. Food and Drug Administration (FDA) has issued a Drug Safety Communication warning that the SGLT2 inhibitors canagliflozin, dapagliflozin, and empagliflozin may result in ketoacidosis, a serious blood condition in which the body produces excess blood acids, or ketones. Ketoacidosis may require hospitalization and in extreme cases can prove fatal. The SLGT2 inhibitors are marketed under the brand names Invokana, Invokamet, Farxiga, Jardiance, Glyxambi, and Xigduo XR.

SGLT2 inhibitors are FDA-approved to help lower blood sugar in adults with type 2 diabetes by inducing the kidneys to remove sugar from the body through urine. Unfortunately, a significant number of ketoacidosis cases have been linked to use of these medicines. According to the FDA, a search of the agency’s Adverse Event Reporting System database “identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014.” All 20 patients required hospitalization or a visit to the emergency room for treatment.

The FDA is unsure of what caused the onset of ketoacidosis in these type 2 diabetes patients, but the agency is nonetheless urging health care experts and patients to take precautions when using SGLT2 inhibitors. Patients are directed to be watchful for any signs of ketoacidosis and seek immediate medical attention should they experience symptoms including difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Doctors are instructed to look for ketoacidosis in patients experiencing these symptoms and discontinue use of any SGLT2 inhibitors if the condition is confirmed.

Consult your doctor or physician before making any changes to your drug treatment plan. If you or a loved one was diagnosed with ketoacidosis after taking an SGLT2 inhibitor, contact Lopez McHugh today to discuss your case with a seasoned pharmaceutical lawyer. You may be eligible to receive compensation for your injuries.