- 24 мая 2019
- benefit-risk balance, CMDh, cough, EMA, EU, fenspiride, heart rhythm problems, MA, medicinal product, medicines, negative, PRAC, QT prolongation, supply, suspended, symptomatic treatment, syrup, tablet, torsades de pointes, withdrawal of MA, withdrawal of marketing authorisation, дополнительные исследования, удлинение интервалов QT на электрокардиограмме, фенспирид,
EMA’s safety committee (PRAC) has recommended that the marketing authorisations for fenspiride medicines be revoked, so the medicines can no longer be marketed in the EU. This follows a review that has confirmed that these cough medicines could cause heart rhythm problems.
The PRAC considered all the available evidence in its review. This included cases of QT prolongation and torsades de pointes (abnormalities of the heart’s electrical activity that may lead to heart rhythm disturbances) 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.
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. Therefore, the PRAC considered that these medicines should no longer be marketed.
Fenspiride medicines are available as syrup or tablets and used in adults and children from the age of 2 years to relieve cough resulting from lung diseases. In the EU, fenspiride medicines have been authorised via national procedures in Bulgaria, France, Latvia, Lithuania, Poland, Portugal and Romania therefore the PRAC recommendation will now be sent to the CMDh to make a decision about its implementation.
List of the medicines affected can be reached here.
The review of fenspiride was initiated on 14 February 2019 at the request of France, under Article 107i of Directive 2001/83/EC. At that time, the Pharmacovigilance Risk Assessment Committee (PRAC) recommended that supply of fenspiride medicines be suspended as a precautionary measure while the review was ongoing.