EMA committee reviews amputation rates during treatment with Invokana (canagliflozin) in type 2 diabetes- Janssen Pharmaceuticals

The EU's Pharmacovigilance Risk Assessment Committee has started a review of the diabetes medicine Invokana (canagliflozin), from Janssen Pharmaceuticals, after an increase in amputations mostly affecting toes was observed in an ongoing clinical trial called CANVAS. Cases of lower limb amputation occurred in both the canagliflozin and placebo groups in the trial and the possibility that canagliflozin increases lower limb amputations is currently not confirmed. The EMA’s 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 EU.

A small, non-statistically significant increase in the number of amputations occurred in another ongoing study called CANVAS-R. Both CANVAS and CANVAS-R involve patients at high risk of problems with the heart and blood vessels. The PRAC will also ask for data on other medicines in the same class known as SGLT2 inhibitors1. Based on this, the PRAC may decide to extend the scope of the review to cover these medicines.