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
Table of contents
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
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Approved name |
Bromocriptine-containing medicines indicated in the prevention or suppression of physiological lactation post-partum
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International non-proprietary name (INN) or common name |
bromocriptine
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About this procedure
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Current status |
European Commission final decision
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Reference number |
EMEA/H/A-31/1379
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Type | |
Authorisation model |
Nationally authorised product(s)
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Decision making model |
PRAC-CMDh
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Key dates and outcomes
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Procedure start date |
05/09/2013
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PRAC recommendation date |
10/07/2014
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CHMP opinion/CMDh position date |
20/08/2014
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EC decision date |
30/10/2014
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Outcome |
Variation
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All documents
Procedure started
Bromocriptine Article-31 referral - Annex I (PDF/152.23 KB)
First published: 06/09/2013
Last updated: 06/09/2013
EMA/541119/2013
Bromocriptine Article-31 referral - PRAC list of questions (PDF/78.27 KB)
First published: 06/09/2013
Last updated: 06/09/2013
EMA/PRAC/493207/2013
Bromocriptine Article-31 referral - Notification (PDF/101.19 KB)
First published: 06/09/2013
Last updated: 06/09/2013
Bromocriptine Article-31 referral - Review started (PDF/67.19 KB)
First published: 06/09/2013
Last updated: 06/09/2013
EMA/533713/2013
Bromocriptine Article-31 referral - Timetable for the procedure (PDF/85.13 KB)
First published: 06/09/2013
Last updated: 02/09/2014
EMA/PRAC/493206/2013 rev. 2
Recommendation provided by Pharmacovigilance Risk Assessment Committee
Bromocriptine Article-31 referral - PRAC assessment report (PDF/248.2 KB)
First published: 02/09/2014
Last updated: 02/09/2014
Bromocriptine Article-31 referral - PRAC recommends restricted use of bromocriptine for stopping breast milk production (PDF/70.32 KB)
First published: 11/07/2014
Last updated: 11/07/2014
EMA/409529/2014
Position provided by CMDh
European Commission final decision
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
Bromocriptine Article-31 referral - Annex I (PDF/144.72 KB)
First published: 02/09/2014
Last updated: 08/12/2014
Bromocriptine Article-31 referral - Annex II (PDF/62.22 KB)
First published: 02/09/2014
Last updated: 08/12/2014
Bromocriptine Article-31 referral - CMDh divergent position (PDF/54.15 KB)
First published: 02/09/2014
Last updated: 08/12/2014
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.