Canagliflozin (kan" a gli floe' zin; Invokana – Janssen), a sodium-glucose co-transporter 2 (SGLT2) inhibitor, has been approved by the FDA for oral treatment of type 2 diabetes.

The FDA has removed a boxed warning from the labeling of products containing the sodium-glucose co-transporter 2 (SGLT2) inhibitor canagliflozin (Invokana, Invokamet, Invokamet XR) that described an increased risk of lower limb amputation associated with use of the drug. Package inserts for canagliflozin products still contain a standard warning about a risk of lower limb amputation.

The recent report of a reduction in cardiovascular mortality in patients with type 2 diabetes treated with the SGLT2 inhibitor empagliflozin (Jardiance) was published soon after the FDA issued new warnings about an increased risk of fractures with canagliflozin (Invokana).

The sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance – Boehringer Ingelheim/Lilly) is now FDA-approved to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease (CKD) at risk of progression. It is also approved to improve glycemic control in patients ≥10 years old with type 2 diabetes, to reduce the risk of cardiovascular death and hospitalization for heart failure (HF) in adults with HF, and to reduce the risk of cardiovascular death in adults with type...

At the same time that the FDA announced it was strengthening existing warnings about the risk of acute kidney injury in patients with type 2 diabetes treated with the sodium-glucose co-transporter 2 (SGLT2) inhibitors canagliflozin (Invokana, and others) and dapagliflozin (Farxiga, and others), a study was published showing that the third SGLT2 inhibitor, empagliflozin (Jardiance, and others), slowed the progression of renal dysfunction in patients with type 2 diabetes.

The FDA has warned that use of an SGLT2 (sodium-glucose co-transporter 2) inhibitor for treatment of type 2 diabetes may lead to ketoacidosis.1 Three SGLT2 inhibitors, canagliflozin (Invokana, Invokamet), dapagliflozin (Farxiga, Xigduo XR), and empagliflozin (Jardiance, Glyxambi), are approved for treatment of type 2 diabetes in the US. Between March 2013 and June 2014, 20 cases of ketoacidosis requiring emergency room visits or hospitalization were reported in patients who had recently started taking an SGLT2 inhibitor; the median time to onset of symptoms after initiation of therapy was 2...

The FDA has approved fixed-dose combinations of metformin with either canagliflozin (Invokamet) or dapagliflozin (Xigduo XR) for treatment of patients with type 2 diabetes not adequately controlled with any one of these drugs, or in those already being treated with both metformin and either canagliflozin or dapagliflozin.

Dapagliflozin (dap" a gli fl oe' zin; Farxiga – Bristol-Myers Squibb/AstraZeneca), an SGLT2 (sodium-glucose co-transporter 2) inhibitor, has been approved by the FDA for oral treatment of type 2 diabetes. Dapagliflozin is the second SGLT2 inhibitor to be approved for this indication; canagliflozin (Invokana) was the first .

In a randomized, placebo-controlled trial, the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance – Boehringer Ingelheim/Lilly) reduced the composite risk of cardiovascular death or hospitalization for worsening heart failure (HF) in patients with heart failure with reduced ejection fraction (HFrEF), whether or not they had type 2 diabetes. To date, empagliflozin has not been approved by the FDA for such use. The SGLT2 inhibitor dapagliflozin (Farxiga) was approved by the FDA for this indication earlier this year.

The sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance – Boehringer Ingelheim) was approved by the FDA in 2021 to reduce the risk of hospitalization for heart failure (HF) and cardiovascular death in patients with heart failure with reduced ejection fraction (HFrEF; LVEF ≤40%), regardless of whether or not they have type 2 diabetes. The indication has now been expanded to include patients with HF with any ejection fraction. Empagliflozin is the first SGLT2 inhibitor to be approved in the US for this indication.