EMA Suspends Cough Medicine Over Heart Rhythm Fears
European regulators have banned cough medicines containing fenspiride amid concerns that it can cause irregular heartbeats.
Developed by French drugmaker Servier and marketed as Pneumorel, fenspiride was authorized in seven EU member states under almost a dozen brand names. But the European Medicines Agency ordered new rounds of animal testing after some patients complained about irregular heartbeats. The results suggest that the antitussive may cause electrical abnormalities that disrupt the heart’s regular beat.
The EMA said it plans to conduct a more thorough review of the drug and provide updated guidance.