EMA’s safety committee (PRAC) has started a review of the risk of QT prolongation and torsades de pointes (abnormalities of the heart’s electrical activity that may lead to heart rhythm disturbances) with fenspiride medicines. Fenspiride is used in children and adults in a number of European Union Member States to relieve cough caused by lung diseases. As a precaution to protect patients, the PRAC has decided to suspend these products while the review is ongoing. Healthcare professionals should advise their patients to stop taking fenspiride medicines.

The PRAC will examine all the available evidence and make recommendations on the action to be taken on marketing authorisations for these treatments across the EU.

Posted on the EMA website on 15 February 2019