Bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum

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

Overview

Restrictions in use of bromocriptine for stopping breast milk production

The medicine should not be used routinely for preventing or stopping milk production after childbirth

On 20 August 2014, the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)1 endorsed by majority recommendations on the use of bromocriptine-containing medicines by mouth to prevent or suppress breast milk production (lactation) after childbirth.

The CMDh agreed that the medicines should only be used for this purpose (in strengths up to 2.5 mg) when there are compelling medical reasons for stopping lactation, such as the need to avoid further distress after loss of the baby during or just after childbirth, or in mothers with HIV infection, who should not breastfeed.

Bromocriptine should not be used routinely for preventing or stopping milk production, and must not be used in women at increased risk of serious side effects, including women with various disorders that increase blood pressure or who have or have had heart disease or severe psychiatric disorders. Blood pressure should be monitored so that early signs of an increase can be detected and treatment stopped immediately.

The CMDh position followed a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) of available data on the safety and effectiveness of bromocriptine in controlling breast milk production after childbirth, which led to these recommendations. The review was triggered by concerns in France over increased reports of rare but potentially serious or fatal side effects, particularly cardiovascular side effects (such as heart attack and stroke), neurological side effects such as seizures (fits) and psychiatric side effects (such as hallucinations and manic episodes). Since lactation is a natural process that eventually stops if the infant is not breastfed, and other means of management are available, the French medicines agency (ANSM) asked the EMA to review the medicines and see if the benefits of such use still outweighed the risks.

As the CMDh position on bromocriptine was adopted by majority vote, it was sent to the European Commission, which took an EU-wide legally binding decision on 30 October 2014.


1The CMDh is a medicines regulatory body representing the European Union (EU) Member States.

Key facts

About this medicine
Approved name
Bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum
International non-proprietary name (INN) or common name
bromocriptine
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1379
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
05/09/2013
PRAC recommendation date
10/07/2014
CHMP opinion/CMDh position date
20/08/2014
EC decision date
30/10/2014
Outcome
Variation

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Position provided by CMDh

European Commission final decision

  • List item

    Bromocriptine Article-31 referral - Restrictions in use of bromocriptine for stopping breast milk production (PDF/88.97 KB)


    First published: 08/12/2014
    Last updated: 08/12/2014
    EMA/698187/2014

  • List item

    Bromocriptine Article-31 referral - Annex I (PDF/144.72 KB)


    First published: 02/09/2014
    Last updated: 08/12/2014

  • List item

    Bromocriptine Article-31 referral - Annex II (PDF/62.22 KB)


    First published: 02/09/2014
    Last updated: 08/12/2014

  • List item

    Bromocriptine Article-31 referral - CMDh divergent position (PDF/54.15 KB)


    First published: 02/09/2014
    Last updated: 08/12/2014

  • List item

    Bromocriptine Article-31 referral - Annex III (PDF/41.4 KB)


    First published: 21/08/2014
    Last updated: 08/12/2014

  • 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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