Fenspiride containing medicinal products

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Under evaluation
PRAC recommendation
CMDh position
European Commission final decision

Overview
Key facts
Data submission
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Current status:

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Overview

Suspension of fenspiride medicines due to potential risk of heart rhythm problems

EMA’s safety committee (PRAC) has recommended an EU-wide suspension of fenspiride medicines, used in children and adults to relieve cough caused by lung diseases.

The suspension is a precautionary measure to protect patients while the PRAC reviews the risk of QT prolongation and torsades de pointes (abnormalities of the heart’s electrical activity that may lead to heart rhythm disturbances).

Cases of heart rhythm problems had been reported in patients who had taken these medicines in the past. To explore the potential link between fenspiride and these heart rhythm problems, animal studies were carried out which now show that fenspiride has the potential to prolong QT in humans.

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. Once the review is concluded, EMA will communicate further and provide updated guidance to patients and healthcare professionals.

The Agency invites all stakeholders (e.g. healthcare professionals, patients’ organisations, and the general public) to submit data relevant to this procedure. Full details are available in the ‘Data submission’ section.

Safety data indicate that cough medicines containing fenspiride could cause sudden serious heart rhythm problems.
While authorities review all the evidence, patients are advised to stop taking these medicines.
Patients are only at risk of heart rhythm problems with fenspiride while they are taking these medicines.
If you are taking a cough medicine containing fenspiride, contact your doctor or pharmacist for advice on alternative treatments, if needed.
If you have any concerns about your medicine, discuss them with your doctor or pharmacist.

As a precaution and while the review is ongoing, healthcare professionals should advise their patients to stop taking fenspiride medicines.
The provisional suspension of fenspiride medicines is based on recent nonclinical studies (hERG channel binding and in vitro animal model studies) that showed that fenspiride has the potential to increase QT intervals in humans. These data were supportive of a previously suspected link between fenspiride and QT prolongation/torsades de pointes in humans, which was based on a limited number of case reports.

Given the authorised use of fenspiride for symptomatic treatment only and the seriousness of QT prolongation, the medicines are provisionally suspended pending the results of an urgent EU safety review.
Healthcare professionals will be informed in writing about the suspension, and further information will be provided as needed and once the review has concluded.

: 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, Еуреспал and Сиресп).

: The review of fenspiride has been initiated at the request of France, under Article 107i of Directive 2001/83/EC.
The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines. While the review is ongoing the PRAC has recommended suspending the medicines to protect public health.
Since fenspiride medicines are all authorised nationally, once the PRAC concludes its review, its recommendations will be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which will adopt a position. 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 across the EU.

List item

Fenspiride containing medicinal products Article-107i referral - Suspension of fenspiride medicines due to potential risk of heart rhythm problems (PDF/90.81 KB)

First published: 15/02/2019
EMA/114407/2019

Key facts

About this medicine
Approved name	Fenspiride containing medicinal products
International non-proprietary name (INN) or common name	fenspiride
Class	Drugs for obstructive airway diseases

About this procedure
Current status	Procedure started
Reference number	EMEA/H/A-107i/1480
Type	Article 107i procedures 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.
Decision making model	PRAC-CMDh

Key dates and outcomes
Procedure start date	14/02/2019

Data submission

The Agency invites all stakeholders (e.g. healthcare professionals, patients' organisations, the general public) to submit data relevant to this procedure. This is in accordance with Article 107j(1) of Directive 2001/83/EC.

The following requirements apply for data to be considered:

Submissions must be accompanied by the submission form below, with all fields completed. The form must be used with Adobe Reader X+ or Adobe Acrobat X+:
Stakeholder's submission form
Data submitted should make reference to the Pharmacovigilance Risk Assessment Committee (PRAC) questions:
PRAC list of questions to be addressed by stakeholders
The submission of all data should take place by 11 March 2019.

Submitting data

Send the completed form electronically to the stakeholders' submission inbox (public@ema.europa.eu). Specify the name of the medicine in the subject line of the e-mail.

The size of the submission file should not exceed 25 MB. If your attempt to send your data package to the dedicated e-mail address is unsuccessful, please use alternative submission means.

It is of the utmost importance that data are provided promptly, to avoid undermining the safety review. Due to the urgent nature of the procedure, you are strongly advised to submit your data in English.

Protection of personal data

Personal data submitted are subject to data-protection rules as established by Regulation (EC) 45/2001. They will be treated in accordance with the specific privacy statement for public consultations (EMA/310325/2012).

Treatment and publication of data

Data submitted will be received and recorded by the Agency.

The Agency will prepare a list of all submissions received, which will be published as an annex to the PRAC assessment report for transparency purposes and public awareness.

Please note that all data submitted in the context of this procedure may be shared and disclosed in the public domain.

All documents

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