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.
The suspension is a precautionary measure to protect patients while the PRAC reviews the risk of QT prolongation and torsades de pointes (abnormalities of the heart’s electrical activity that may lead to heart rhythm disturbances).
Cases of heart rhythm problems had been reported in patients who had taken these medicines in the past. To explore the potential link between fenspiride and these heart rhythm problems, animal studies were carried out which now show that fenspiride has the potential to prolong QT in humans. The PRAC will now examine all the available evidence and make recommendations on the action to be taken on marketing authorisations for fenspiride medicines across the EU. Once the review is concluded, EMA will communicate further and provide updated guidance to patients and healthcare professionals.
Fenspiride medicines are available as syrup or tablets and used in adults and children from
the age of 2 years to relieve cough resulting from lung diseases.
The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines. While the review is ongoing the PRAC has recommended suspending the medicines to protect public health.
