Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 February 2019
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.
More information is provided below.