On 16 May 2019, EMA’s safety committee (PRAC) recommended that the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be marketed in the EU. This follows a review that confirmed that these cough medicines could cause heart rhythm problems.
The Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the withdrawal of cough medicines containing fenspiride from the European market. PRAC made the recommendation at a meeting at which it also placed temporary restrictions on the use of Pfizer’s Xeljanz.
Withdrawal of marketing authorisations for fenspiride medicines
The European Medicines Agency (EMA) has announced an EU-wide suspension of fenspiride medicines due to a potential risk of heart rhythm problems.
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.
EMA’s safety committee (PRAC) has recommended an EU-wide suspension of fenspiride medicines, used in children and adults to relieve cough caused by lung diseases.