Fenspiride containing medicinal products - referral
Current status
Referral
Human
On 16 May 2019, EMA’s safety committee (PRAC) 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 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. Therefore, the PRAC considered that these medicines should no longer be marketed.
The PRAC recommendation was adopted by the CMDh* by consensus and will be implemented directly at national level.
*Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human
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 and are available under various brand names (Elofen, Epistat, Eurefin, Eurespal, Fenspogal, Fosidal, Kudorp, Pneumorel, Pulneo, ???????? and ??????).
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.
The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
The PRAC recommendation was sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which adopted it by consensus on 29 May 2019. The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway. It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures.
The PRAC recommendation will now be implemented by EU Member States, Iceland, Lichtenstein and Norway.
This type of procedure is triggered when a Member State or the European Commission consider that urgent action is necessary because of a safety issue. Situations that fall under this procedure include consideration for suspension or revocation of the marketing authorisation for a medicine, the prohibition of supply of a medicine or major changes to the marketing authorisation such as deletion of indications, reduction of the recommended dose or new contraindications. The procedure is also applicable in case of a safety issue with a class of medicines.
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
Note that older documents may have different titles.