FDA issues ketoacidosis warning for SGLT2 inhibitors

The FDA issued a warning Friday that SGLT2 inhibitors, which include AstraZeneca's Farxiga (dapagliflozin), Johnson & Johnson's Invokana (canagliflozin), and Eli Lilly and Boehringer Ingelheim's Jardiance (embagliflozin), may lead to ketoacidosis. The agency said it is "continuing to investigate this safety issue," and will determine whether label changes to the diabetes therapies are needed.

According to the FDA, its adverse events 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. The agency said emergency room visits or hospitalisations were required to treat ketoacidosis, adding that potential triggering factors in some reported cases of the condition included major illness, reduced food and fluid intake and lower insulin use. The regulator also noted that the reported cases were unusual for DKA, which typically occurs in type 1 diabetes and is associated with high blood glucose, because most of the patients recorded in the database had type 2 diabetes, with only slightly elevated glucose levels. Meanwhile, the FDA says it has continued to receive reports of ketoacidosis and DKA associated with SGLT2 inhibitors since June 2014.

The agency indicated that its warning also covers combination drugs containing SGLT2 inhibitors, including Johnson & Johnson's Invokamet (canagliflozin/metformin), AstraZeneca's Xigduo XR (dapagliflozin/metformin) and Eli Lilly and Boehringer Ingelheim's Glyxambi (empagliflozin/linagliptin).

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