FDA Issues Safety Alert on Type 2 Diabetes Drugs

The FDA may be considering new label warnings for type 2 diabetes drugs containing the active ingredients canagliflozin, dapagliflozin and empagliflozin, in the wake of reports linking the drugs to a serious blood condition. 

According to a drug safety communication issued last week, the FDA received 20 reports of diabetic ketoacidosis, ketoacidosis or ketosis — high levels of blood acids — in patients treated with the drugs, known as sodium-glucose cotransporter-2 inhibitors, from March 2013 to June 6, 2014. All 20 patients required emergency room visits or hospitalization to treat the condition.

The FDA says it continues to get reports of DKA in patients taking SGLT2 inhibitors, which normally isn’t seen in patients with type 2 diabetes. The median time to onset of symptoms following initiation of drug therapy is two weeks.

Drugs affected by the alert include Janssen’s Invokana and Invokamet, Bristol-Meyers Squibb and AstraZeneca’s Farxiga, AstraZeneca’s Xigduo XR, and Boehringer Ingelheim’s Jardiance and Glyxambi.

The FDA says it will determine if changes in the labeling for this class of drugs are necessary. In the meantime, doctors and patients should report any side effects involving the drugs to the agency’s MedWatch program.

To read the FDA notice, go to www.fdanews.com/05-18-15-SGLT2.pdf. — Kellen Owings