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Extension of the scope of a safety review

The PRAC extended the scope of a review, which initially only covered canagliflozin, to include the other diabetes medicines in the same class, dapagliflozin and empagliflozin.

The Committee had initiated the review of canagliflozin in April 2016 after an increase in amputations mostly affecting toes was observed in an ongoing clinical trial called CANVAS. The scope of this referral was extended because the potential risk being evaluated for canagliflozin may be relevant for the other medicines in this class (SGLT2 inhibitors).

 
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