EMA Recommends Suspension of Fenspiride Medicines

February 22, 2019

The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has issued a recommendation for the suspension of fenspiride medicines across the whole of the European Union.

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has issued a recommendation for the suspension of fenspiride medicines across the whole of the European Union, it was revealed in a Feb. 15, 2019 press release.

Fenspiride medicines are used to relieve coughs caused by lung diseases in children and adults. Due to reports of heart rhythm problems that have occurred in patients who have previously taken the medicines and resultant studies in animals that assessed the link between fenspiride medicines and heart rhythm problems, PRAC decided to take the precautionary measure of an EU-wide suspension to protect patients.

While the suspension is in place, PRAC will review the risk of QT prolongation and torsades de pointes (abnormalities of the heart’s electrical activity that may lead to heart rhythm disturbances). The committee will examine all available evidence on the medicines and the potential link to heart rhythm problems. Then, the committee will make its recommendations on any actions to be taken on the marketing authorizations for the medicines throughout the EU.

Once all assessments and recommendations have been made, EMA will provide further communication and updated guidance to patients and healthcare professionals. 

Source: EMA