The European Medicines Agency's safety committee recommended withdrawing marketing authorizations for cough medicines containing fenspiride after confirming that the drugs cause serious heart rhythm problems.
Fenspiride medicines, marketed as Eurespal and Pneumorel, among others, are used in children and adults to relieve coughs caused by lung diseases. Certain fenspiride-containing medicines are also approved in Russia for treating acute and chronic inflammatory diseases of the ear, nose and throat and the respiratory tract.
The EU agency's Pharmacovigilance Risk Assessment Committee, or PRAC, said its recommendation was based on a review of case reports and nonclinical studies, which showed that fenspiride causes QT prolongation — when the heart muscle takes longer than normal to recharge between beats — and may trigger or worsen arrhythmia, a problem with the rate or rhythm of the heartbeat.
Additionally, the drugs were linked to risk of torsades de pointes, or abnormalities of the heart's electrical activity that may lead to heart rhythm disturbances.
The committee clarified that the risk of developing heart rhythm problems only occur while taking fenspiride drugs.
Healthcare professionals were ordered to refrain from prescribing fenspiride and to advise that their patients stop taking the medicines.
The EMA's Coordination Group for Mutual Recognition and Decentralized Procedures – Human will decide on the implementation of PRAC's recommendation.
Once the marketing authorizations are revoked, cough drugs containing fenspiride will no longer be available in the EU.