The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended a European Union (EU)-wide suspension of fenspiride antitussives.
The provisional suspension of fenspiride medicines is based on recent nonclinical studies (hERG channel binding and in vitro animal model studies) which showed that fenspiride has the potential to increase QT intervals in humans. These data supported a previously suspected link between fenspiride and QT prolongation/torsades de pointes, which was based on a limited number of case reports.
The suspension is a precautionary measure. The PRAC will now examine all the available evidence and make recommendations on the action to be taken on marketing authorisations for fenspiride medicines across the EU.
As a precaution and while the review is ongoing, healthcare professionals should advise patients to stop taking fenspiride medicines, the EMA says. Once the review is concluded, the EMA will provide updated guidance to healthcare professionals.
The agency is inviting all stakeholders, including healthcare professionals, patient organisations and the general public, to submit data relevant to this procedure.
The online submission form is available here. The closing date for receipt of submissions is 11 March 2019.
Relevant brands include Elofen, Epistat, Eurefin, Eurespal, Fenspogal, Fosidal, Kudorp, Pneumorel, Pulneo, Еуреспал and Сиресп.