EMA Will Update SGLT2 Inhibitor Label to Include DKA

February 26, 2016

The European Medicines Agency (EMA) has confirmed the recommendations made 2 weeks ago by its Pharmacovigilance Risk Assessment Committee (PRAC) to minimize the risk of diabetic ketoacidosis with use of sodium-glucose cotransporter-2 (SGLT2) inhibitors, a relatively new class of oral medications used to treat type 2 diabetes.

Following a review of the cases, the EMA has recommended updating the product information of SGLT2 inhibitors licensed in the European Union; these will now list diabetic ketoacidosis as a rare adverse event, affecting up to one in 1000 patients.

These products include empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly), canagliflozin (Invokana, Johnson & Johnson/Janssen), and dapagliflozin (Edistride, Forxiga, AstraZeneca/Bristol-Myers Squibb), and those drugs in combination with metformin under the following trade names: Ebymect, Synjardy, Vokanamet, and Xigduo.

As the PRAC noted, presentation of DKA in patients taking SGLT2 inhibitors is often atypical, with patients not having blood glucose levels as high as expected, the EMA notes.

EMA reiterates the advice given by the PRAC regarding the symptoms patients and physicians should watch out for and stresses to doctors that "SGLT2 inhibitors are not authorized for type 1 diabetes," noting that cases of ketoacidosis have occurred "during off-label use and clinical trials in type 1 diabetes."

But "the benefits of these medicines continue to outweigh the risks in the treatment of type 2 diabetes," EMA concludes.

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