EMA's pharmacovigilance unit PRAC concludes one safety referral and starts two others

At its meeting this week, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency concluded a safety review and started two new ones.

The PRAC concludes that diabetes medicine canagliflozin, marketed by US healthcare giant Johnson & Johnson’s (NYSE: JNJ) Janssen units as Invokana/Invokamet, may contribute to risk of toe amputation and that this risk may also apply to other medicines in the same class. The PRAC warns that an increase in cases of lower limb amputation, mostly affecting the toes, has been observed in patients taking the type 2 diabetes medicine canagliflozin compared with those taking placebo, in two ongoing clinical trials involving patients at high risk of heart problems.

An increased risk has not been seen in studies with other medicines in the same class, dapagliflozin AstraZeneca’s (LSE: AZN) Forxiga, and empagliflozin, Jardiance from Boehringer Ingelheim and Eli Lilly (NYSE: LLY). However, for these medicines, data available to date are limited and the risk may also apply to these other medicines.