Medicinal Products

PRAC News – February 2016


Updated recommendations to minimise the risk of the rare brain infection PML with Tysabri

At its February 2016 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) completed its review of the risk of progressive multifocal leukoencephalopathy (PML) with the multiple sclerosis medicine Tysabri (natalizumab) and recommended new measures to minimise this risk. PML is a rare and very serious brain infection caused by John Cunningham (JC) virus. The Committee's new advice aims to help early detection of PML and improve patients’ outcomes.

More information is available on the HALMED portal.

PRAC recommends stopping the marketing of fusafungine nose and mouth sprays

The Committee recommended that the marketing authorisation for fusafungine-containing medicines be revoked, so the medicines can no longer be marketed in the European Union (EU). This follows a review by the PRAC which concluded that the benefits of fusafungine did not outweigh its risks, particularly the risk of serious allergic reactions. Fusafungine is an antibiotic and anti-inflammatory nose and mouth spray used to treat upper airway infections such as rhinopharyngitis (common cold).

In the Republic of Croatia there are no authorised medicinal products containing fusafungine.

More information is available on EMA's website.

SGLT2 inhibitors: recommendations to minimise risk of diabetic ketoacidosis

The PRAC finalised a review of SGLT2 inhibitors (a class of type 2 diabetes medicines) and has made recommendations to minimise the risk of diabetic ketoacidosis.

Diabetic ketoacidosis is a serious complication of diabetes caused by low insulin levels. Rare cases of this condition, including life-threatening ones, have occurred in patients taking SGLT2 inhibitors for type 2 diabetes. There are currently three SGLT2 inhibitors authorised in the EU (canagliflozin, dapagliflozin and empagliflozin).

More information is available on the HALMED portal.

More information on the February 2016 PRAC meeting can be found here.