The European Medicines Agency (EMA) has suspended cough medicine containing fenspiride with immediate effect. This is due to repeated reports from studies showing that ingestion of the active substance could impair cardiac function.
The temporary ban on fenspiride-containing cough medicines was based on the results of some non-clinical studies which had concluded that fenspiride could potentially contribute to long QT in humans. This seems to confirm the previously postulated suspicion of a connection between fenspiride and a long QT occurrence. This has been previously described in a limited number of case reports.
At the present time, however, the block is a mere precautionary measure. EMA will first examine the entire available evidence and then derive new recommendations. Whether the marketing authorizations for fenspiride drugs in the EU will have to be changed as a result remains to be seen.
In the meantime, EMA advises all physicians to recommend that patients stop taking fenspiride-containing drugs for the duration of this examination. Until then, reference should be made to alternative formulations. Upon completion of the investigation, EMA will issue an updated recommendation for medical professionals.
The following medications are affected by the ban: Elofen, Epistat, Eurefin, Eurespal, Fenspogal, Fosidal, Kudorp, Pneumorel, Pulneo, Еуреспал and Сиресп.
European Medicines Agency. Fenspiride containing medicinal products. 15 February 2019