Fenspiride containing medicinal products

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CMDh position
  • European Commission final decision
Current status:
Procedure started

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. 

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:

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 PDF iconspecific 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

Procedure started

Document description

  • Annex I - List of the medicines affected by the referral
  • Annex II - Scientific conclusions of the CHMP or CMDh
  • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
  • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
  • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
  • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
  • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
  • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
  • PRAC / CHMP or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

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