EMA/PRAC recommends precautionary suspension of fenspiride meds

18 February 2019

Following its February 11-14 meetings, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) on Friday recommended a European Union-wide suspension of fenspiride medicines, used in children and adults to relieve cough caused by lung diseases.

Though now available from a number of drugmakers under various trade names, the drug was developed by French independent Servier and marketed as Pneumorel. In the EU, fenspiride medicines have been authorized via national procedures in Bulgaria, France, Latvia, Lithuania, Poland, Portugal and Romania and are available under various brand names (Elofen, Epistat, Eurefin, Eurespal, Fenspogal, Fosidal, Kudorp, Pneumorel, Pulneo, Еуреспал and Сиресп).

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).

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