Canagliflozin (SGTL2 inhibitor) may increase risk for amputations.

[Argirios Argiriou]

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In May 2017, the FDA issued a boxed warning to the label of canagliflozin after an approximately doubled risk for lower-extremity amputations with the drug compared with placebo was seen during the Canagliflozin Cardiovascular Assessment Study (CANVAS) and A Study of the Effects of Canagliflozin on Renal Endpoints (CANVAS-R) trials. Those findings have since been published.
The same risk has not been seen in studies of the other SGLT2 inhibitors on the market, empagliflozin (Jardiance, Boehringer Ingelheim) and dapagliflozin (Farxiga, AstraZeneca).
Thus far, the FDA has not extended the label warning about amputations to other drugs in the class, although the European Medicines Agency (EMA) has, pending further investigation.
"Our data are the first to confirm the warning originated from CANVAS and tends to suggest this is not a class effect," Dr Fadini told Medscape Medical News.
However, he added, "at the moment, data are not sufficiently robust to modify canagliflozin use in favor of dapagliflozin/empagliflozin. So we can only reinforce, with independent data, the boxed warning issued by the FDA and call for caution when using canagliflozin in patients with the diabetic-foot syndrome."
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