Review Of SGLT Two With Type Two Diabetes And Toe Amputations

The European Medicines Agency (EMA) has begun a review of the sodium glucose cotransporter 2 (SGLT2) inhibitor canagliflozin, used to treat type 2 diabetes, after an increase in amputations, mostly of the toe, was observed in a large ongoing clinical trial of the drug. Cases of lower-limb amputation occurred in both the active drug and placebo groups in the Canagliflozin Cardiovascular Assessment Study (CANVAS), which is the cardiovascular-outcomes trial for this agent and is randomizing just over 4000 type 2 diabetes patients to canagliflozin 100 mg or 300 mg daily or to placebo, slated for completion in 2017.

The EMA Pharmacovigilance Risk Assessment Committee (PRAC) has requested more information from the company to assess whether canagliflozin causes an increase in lower-limb amputations and whether any changes are needed in the way this medicine is used in the European Union. The…