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FDA Issues Safety Warning for Popular Type 2 Diabetes Drugs

The U.S. Food and Drug Administration (FDA) recently issued a safety warning for certain drugs used to treat type 2 diabetes. According to the agency, medicines containing canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, which is a serious and potentially deadly condition where the body produces high levels of blood acids called ketones.

The drugs impacted by the safety communication are known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. The medications, which are sold under the brand names Invokana, Invokamet, Farxiga, Xigduo XR, Jardiance, and Glyxambi, lower blood sugar in diabetes patients by causing the kidneys to remove sugar from the body through the urine.

According to the FDA’s safety announcement, the agency received 20 reports of the medications causing ketoacidosis between March 2013 and June 2014. All of the patients required emergency medical care and were hospitalized. The agency also stated that it continues to receive additional reports about the dangerous side effect of the diabetes medications.

The FDA is currently investigating the safety issue and will determine whether changes are needed in the prescribing information for SGLT2 inhibitors. In the meantime, the FDA advises that patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.

The FDA also warns that health professionals should evaluate patients prescribed SGLT2 inhibitors for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms. The agency also advises that physicians discontinue SGLT2 inhibitors if acidosis is confirmed and take appropriate measures to correct the acidosis and monitor sugar levels.

If you or someone you love has been seriously injured by a dangerous or defective drug or medical device, don’t hesitate to contacta San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.