The European Medicines Agency (EMA) has announced an EU-wide suspension of fenspiride medicines due to a potential risk of heart rhythm problems.
The decision is based on recent nonclinical studies (hERG channel binding and in vitro animal model studies) that showed that fenspiride has the potential to increase QT intervals in humans.
The medicine, used in children and adults to relieve cough caused by lung diseases, has been suspended as a precautionary measure to protect patients while The Pharmacovigilance Risk Assessment Committee (PRAC) reviews the risk of QT prolongation, which can lead to a life threatening ventricular arrhythmia known as torsades de pointes and can result in sudden cardiac death.
Cases of heart rhythm problems had been reported in patients who had taken these medicines in the past, and so to explore the potential link with fenspiride, animal studies were carried out. These show that fenspiride has the potential to prolong QT in humans. While authorities review all the evidence, patients are advised to stop taking these medicines.
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.