The European Medicines Agency (EMA) has recommended revoking EU marketing authorisations for fenspiride medicines amid safety concerns.
The decision is based on a review of data from recent non-clinical studies (hERG channel binding and in vitro animal model studies), which was requested by the French medicines regulatory agency on 14 February 2019. The review, carried out by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), concluded that fenspiride can cause QT prolongation and has proarrhythmic potential, with the associated risk of torsades de pointes.
“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,” the PRAC said in a statement.
Healthcare professionals should no longer prescribe fenspiride medicines and should advise patients to stop taking fenspiride-containing products, the PRAC advises.
The PRAC recommendation will now be sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) for implementation in EU Member States as well as Iceland, Liechtenstein and Norway.