News and Educations

Meeting highlights from the PRAC meeting in February 2017


At its meeting in February 2017, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded a safety review and started a new one. PRAC also started the review of Uptravi (selexipag) in the context of a safety signal and discussed two ongoing referrals.

PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation

PRAC concluded the review of diabetes medicines from the SGLT2 inhibitors group, initiated after an increase in cases of lower limb amputation (mostly affecting the toes) has been observed in patients taking canagliflozin in two clinical trials, CANVAS and CANVAS-R, compared with patients taking placebo. The studies, which are still ongoing, involved patients at high risk of heart problems.
An increased risk has not been seen in studies with other medicines in the same class, dapagliflozin and empagliflozin. However, data available to date are limited and the risk may also apply to these other medicines.
On the basis of the available data, the PRAC recommends that a warning on the risk of lower limb amputation should be included in the prescribing information for these medicines, highlighting the importance of routine preventative foot care.

More information can be found on HALMED's website.

PRAC to review persistence of side effects known to occur with quinolone and fluoroquinolone antibiotics

The PRAC is reviewing systemic and inhaled quinolone and fluoroquinolone antibiotics to evaluate the persistence of serious side effects mainly affecting muscles, joints and the nervous system. Quinolones and fluoroquinolones are widely prescribed in the EU and are important options for treating serious, life-threatening bacterial infections.

The review has been started at the request of the German medicines authority (BfArM) following reports of long-lasting side effects in the national safety database and the published literature. These side effects have already been known, and have been included in the product information for these medicines.

More information can be found on HALMED's website.

More information on the February 2017 PRAC meeting can be found here.