BRUSSELS, Feb. 24 (Xinhua) -- The European Medicines Agency (EMA) on Friday warned that protein SGLT2 inhibitors canagliflozin, dapagliflozin and empagliflozin used for type 2 diabetes might increase risk of lower limb amputation.
According to EMA, all patients with diabetes are at higher risk of infection and ulcers and a warning of the potential increased risk of toe amputation would be included in the prescribing information for these medicines.
EMA also recommended that patients taking these medicines check their feet regularly and follow the doctor's advice on routine preventative foot care.
Doctors need to consider stopping treatment with canagliflozin if patients develop significant foot complications such as infection or skin ulcers, it said.
The mechanism by which canagliflozin might increase the risk of amputation was unclear so far, said EMA.
The review of SGLT2 inhibitors was carried out by EMA's Pharmacovigilance Risk Assessment Committee. These recommendations have been endorsed by the Committee for Medicinal Products for Human Use and would be sent to the European Commission for a final legally-binding decision valid throughout the European Union.
