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 | |
Decision making model |
PRAC-CMDh
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Authorisation model |
Nationally authorised product(s)
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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
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