Gadolinium-containing contrast agents
- Procedure started
- Under evaluation
- PRAC recommendation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
EMA's final opinion confirms restrictions on use of linear gadolinium agents in body scans
Recommendations conclude EMA's scientific review of gadolinium deposition in brain and other tissues
On 20 July 2017, the European Medicines Agency (EMA) concluded its review of gadolinium contrast agents,
confirming recommendations
to restrict the use of some linear gadolinium agents used in MRI body scans and to suspend the authorisations of others.
The recommendations – confirmed by EMA's Committee for Medicinal Products for Human Use (CHMP) – followed a review that found that gadolinium deposition occurs in brain tissues following use of gadolinium contrast agents.
There is currently no evidence that gadolinium deposition in the brain has caused any harm to patients; however EMA has recommended restrictions and suspensions for some intravenous linear agents in order to prevent any risks that could potentially be associated with gadolinium brain deposition.
The intravenous linear agents gadoxetic acid and gadobenic acid can continue to be used for liver scans because they are taken up in the liver and meet an important diagnostic need. In addition, gadopentetic acid given intra-articularly (into the joint) can continue to be used for joint scans because the dose of gadolinium used for joint injections is very low.
All other intravenous linear products (gadodiamide, gadopentetic acid and gadoversetamide) should be suspended in the EU.
Another class of gadolinium agents known as macrocyclic agents (gadobutrol, gadoteric acid and gadoteridol) are more stable and have a lower propensity to release gadolinium than linear agents. These products can continue to be used in their current indications but in the lowest doses that enhance images sufficiently and only when unenhanced body scans are not suitable.
The suspensions or restrictions on linear agents can be lifted if the companies concerned provide evidence of new benefits in an identified patient group that outweigh the risk of brain deposition or if the companies can modify their products so they do not release gadolinium significantly or cause its retention in tissues.
EMA's scientific review of gadolinium deposition in brain and other tissues is now concluded. The final recommendations have been sent to the European Commission, which issued a final legally binding decision applicable in all EU Member States.
Product | Type (formulation) | Recommendation |
---|---|---|
Artirem / Dotarem (gadoteric acid) | macrocyclic (i.v.) | maintain |
Artirem / Dotarem (gadoteric acid) | macrocyclic (intra-articular) | maintain |
Gadovist (gadobutrol) | macrocyclic (i.v.) | maintain |
Magnevist (gadopentetic acid) | linear (intra-articular) | maintain |
Magnevist (gadopentetic acid) | linear (i.v.) | suspend |
Multihance (gadobenic acid) | linear (i.v.) | restrict use to liver scans |
Omniscan (gadodiamide) | linear (i.v.) | suspend |
Optimark (gadoversetamide) | linear (i.v.) | suspend |
Primovist (gadoxetic acid) | linear (i.v.) | maintain |
Prohance (gadoteridol) | macrocyclic (i.v.) | maintain |
Key facts
About this medicine
|
|
---|---|
Approved name |
Gadolinium-containing contrast agents
|
International non-proprietary name (INN) or common name |
|
Associated names |
Optimark
|
Class |
-
|
About this procedure
|
|
---|---|
Current status |
European Commission final decision
|
Reference number |
EMEA/H/A-31/1437
|
Type | |
Authorisation model |
Centrally and nationally authorised products (mixed)
|
Decision making model |
PRAC-CHMP-EC
|
Key dates and outcomes
|
|
---|---|
Procedure start date |
17/03/2016
|
PRAC recommendation date |
06/07/2017
|
CHMP opinion/CMDh position date |
20/07/2017
|
EC decision date |
23/11/2017
|
Outcome |
Suspension
|
All documents
Procedure started
Gadolinium Article-31 referral - Annex I (PDF/313.02 KB)
First published: 18/03/2016
Last updated: 26/04/2016
EMA/207286/2016
Gadolinium Article-31 referral – PRAC list of questions (PDF/108.54 KB)
First published: 18/03/2016
Last updated: 18/03/2016
EMA/PRAC/188631/2016
Gadolinium Article-31 referral - Review started (PDF/88.92 KB)
First published: 18/03/2016
Last updated: 18/03/2016
EMA/200364/2016
Gadolinium Article-31 referral – Timetable for the procedure (PDF/79.16 KB)
First published: 18/03/2016
Last updated: 30/05/2017
EMA/PRAC/195601/2016 Rev.7
Gadolinium Article-31 referral – Notification (PDF/48.19 KB)
First published: 18/03/2016
Last updated: 18/03/2016
Recommendation provided by Pharmacovigilance Risk Assessment Committee
Gadolinium Article-31 referral – PRAC confirms restrictions on the use of linear gadolinium agents (PDF/67.88 KB)
First published: 07/07/2017
Last updated: 07/07/2017
EMA/424715/2017
Gadolinium Article-31 referral – PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations (PDF/72.58 KB)
First published: 10/03/2017
Last updated: 07/04/2017
EMA/157486/2017
Opinion provided by Committee for Medicinal Products for Human Use
Gadolinium Article-31 referral – Annex III (PDF/68.69 KB)
First published: 21/07/2017
Last updated: 21/07/2017
Gadolinium Article-31 referral – EMA’s final opinion confirms restrictions on use of linear gadolinium agents in body scans (PDF/85.46 KB)
First published: 21/07/2017
Last updated: 21/07/2017
EMA/457616/2017
European Commission final decision
Gadolinium Article-31 referral – Annex III (PDF/72.49 KB)
First published: 19/12/2017
Last updated: 19/12/2017
Gadolinium Article-31 referral – Annex IV (PDF/26.28 KB)
First published: 19/12/2017
Last updated: 19/12/2017
Gadolinium Article-31 referral – EMA’s final opinion confirms restrictions on use of linear gadolinium agents in body scans (PDF/104.44 KB)
First published: 19/12/2017
Last updated: 19/12/2017
EMA/625317/2017
Gadolinium Article-31 referral – Annex II (PDF/135.69 KB)
First published: 19/12/2017
Last updated: 19/12/2017
Gadolinium Article-31 referral – CHMP divergent positions (PDF/59.4 KB)
First published: 19/12/2017
Last updated: 19/12/2017
Gadolinium Article-31 referral – Annex I (PDF/305.84 KB)
First published: 19/12/2017
Last updated: 19/12/2017
Gadolinium Article-31 referral - Assessment report (PDF/1.34 MB)
First published: 04/12/2017
Last updated: 04/12/2017
EMA/411650/2017
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.
News
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21/07/2017
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21/07/2017
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07/07/2017
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07/04/2017
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10/03/2017
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10/03/2017
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13/01/2017
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28/10/2016
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30/09/2016
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02/09/2016
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10/06/2016
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13/05/2016
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15/04/2016
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18/03/2016