Almitrine-containing medicines

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

Overview


Oral almitrine to be withdrawn by EU Member States

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), a medicines regulatory body representing the European Union (EU) Member States, has endorsed the recommendation by the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC), that permission to market oral medicines containing almitrine should be withdrawn across the EU.

As the PRAC recommendation was endorsed by consensus by the CMDh, it will now be implemented directly by the Member States where oral almitrine is authorised, according to an agreed timetable, which should be completed by 25 July 2013.

Almitrine is a stimulant of the part of the brain responsible for the breathing reflex. In the EU, it is authorised in France, Poland and Portugal to be taken orally for the treatment of chronic respiratory failure (inability of the lungs to take in oxygen and get rid of carbon dioxide properly), which is associated with hypoxaemia (lower than normal levels of oxygen in the blood). These conditions pose a particular problem in patients with lung conditions known as chronic obstructive pulmonary disease (COPD), where the airways and air sacs inside the lungs become damaged or blocked.

The safety review of oral almitrine was requested by the French medicines agency, the National Agency for the Safety of Medicine and Health Products (ANSM), because of concerns about side effects and a view that the available evidence did not support the use of the medicine in the current management of COPD. The PRAC concluded that there is a clear association between oral almitrine treatment and potentially serious and long-lasting peripheral neuropathy (damage to the nerves in the hands and feet) and significant weight loss that further weakens patients. The PRAC noted that cases continue to be reported even after additional precautions on the use of the medicines were put in place. Furthermore, oral almitrine is no longer included as a recommended therapy in international treatment guidelines for the management of COPD.

The CMDh agreed with the PRAC conclusion that the benefits of these medicines do not outweigh their risks, and adopted a final position that the marketing authorisations should be withdrawn throughout the EU.

Key facts

About this medicine
Approved name
Almitrine-containing medicines
International non-proprietary name (INN) or common name
almitrine
Associated names
  • Vectarion
  • Armanor
About this procedure
Current status
Position provided by CMDh
Reference number
EMEA/H/A-31/1346
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Decision making model
PRAC-CMDh
Authorisation model
Nationally authorised product(s)
Key dates and outcomes
Procedure start date
29/11/2012
PRAC recommendation date
16/05/2013
CHMP opinion/CMDh position date
29/05/2013
Outcome
Suspension

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Position provided by CMDh

  • List item

    Almitrine Article-31 - Oral almitrine to be withdrawn by EU Member States (PDF/94.05 KB)


    First published: 31/05/2013
    Last updated: 31/05/2013
    EMA/313994/2013

  • List item

    Almitrine Article-31 referral - Annex I (PDF/28.55 KB)


    First published: 10/06/2013
    Last updated: 10/06/2013

  • List item

    Almitrine Article-31 referral - Annex II (PDF/88.64 KB)


    First published: 10/06/2013
    Last updated: 02/12/2013

  • List item

    Almitrine Article-31 referral - Annex III (PDF/39.38 KB)


    First published: 10/06/2013
    Last updated: 02/12/2013

  • List item

    Almitrine Article-31 - Oral almitrine to be withdrawn by EU Member States (PDF/94.05 KB)


    First published: 31/05/2013
    Last updated: 31/05/2013
    EMA/313994/2013

  • 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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