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

  • Description of documents published

    Please note that some of the listed documents apply only to certain procedures.

    • Overview - lay-language summary of the stage of the procedure
    • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
    • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
    • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
    • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
    • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
    • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
    • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
    • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
    • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
    • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
    • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
    • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
    • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
    • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

    Note that older documents may have different titles.

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