European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended to revoke the marketing authorisations for fenspiride medicines, following a review that confirming the risk of heart rhythm problems with this cough medicines.
The PRAC considered all the available evidence in its review. This included cases of QT prolongation and torsades de pointes in patients using these medicines, results of laboratory studies, data from published literature and stakeholder input.
Heart rhythm problems can be serious and occur suddenly, and it is not feasible to identify in advance the patients who may be at risk of these problems with fenspiride. In contrast, fenspiride medicines are used to treat non-serious cough. Therefore, the PRAC considered that these medicines should no longer be marketed.
The PRAC recommendation will now be sent to the CMDh1 to make a decision about its implementation. The CMDh is a body representing the EU Member States as well as Iceland, Liechtenstein and Norway.
Given the authorised uses of fenspiride for symptomatic treatment only and the seriousness of the safety concern, the benefit-risk balance of these medicines is negative for the currently authorised uses.