News > Medscape Medical News EU Panel Recommends Fenspiride Suspension Because of Heart Risks Megan Brooks torsades de pointes has promoted the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) to recommend suspending use of the drug in Europe for now. "The suspension is a precautionary measure to protect patients while the PRAC reviews the risk of QT prolongation and torsades de pointes," the EMA said in a statement. 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. Heart rhythm problems have been reported in some patients using these medicines in the past. Recent nonclinical studies indicate that fenspiride has the potential to increase QT intervals in humans. "Given the authorized use of fenspiride for symptomatic treatment only and the seriousness of QT prolongation, the medicines are provisionally suspended pending the results of an urgent EU safety review," the EMA said. "As a precaution and while the review is ongoing, healthcare professionals should advise their patients to stop taking fenspiride medicines," the EMA said. In the European Union, fenspiride medicines have been authorized 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 drug is not approved in the United States.
