Hydroxyethyl starch solutions for infusion
- Procedure started
- Under evaluation
- PRAC recommendation
- CMDh position
- European Commission final decision
Table of contents
Overview
Hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients
HES will be available in restricted patient populations
On 23 October 2013, the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh)*, endorsed by majority the recommendations of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that HES solutions must no longer be used to treat patients with sepsis (bacterial infection in the blood) or burn injuries or critically ill patients because of an increased risk of kidney injury and mortality.
HES solutions may continue to be used in patients to treat hypovolaemia (low blood volume) caused by acute (sudden) blood loss, where treatment with alternative infusions solutions known as 'crystalloids' alone are not considered to be sufficient. In order to minimise potential risks in these patients, HES solutions should not be used for more than 24 hours and patients' kidney function should be monitored after HES administration. In addition to updating the product information, further studies should be carried out on the use of these medicines in elective surgery and trauma patients.
The review of HES solutions was carried out by the PRAC following the publication of studies showing an increased risk of mortality in patients with sepsis1,2 and an increased risk of kidney injury requiring dialysis in critically ill patients1,2,3 following treatment with HES solutions.
As the CMDh position was adopted by majority vote, it was sent to the European Commission, which endorsed it and, on 19 December 2013, adopted a final legally binding decision valid throughout the European Union (EU).
* The CMDh is a medicines regulatory body representing the European Union (EU) Member States
Key facts
About this medicine
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Approved name |
Hydroxyethyl starch solutions for infusion
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International non-proprietary name (INN) or common name |
hydroxyethyl starch |
Class |
-
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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-31/1348
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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 |
29/11/2012
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PRAC recommendation date |
10/10/2013
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CHMP opinion/CMDh position date |
23/10/2013
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EC decision date |
19/12/2013
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Outcome |
Risk minimisation measures
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All documents
Procedure started
Hydroxyethyl starch Article-31 referral - Timetable for the procedure (PDF/72.27 KB)
First published: 30/11/2012
Last updated: 02/09/2013
EMA/PRAC/751078/2012
Hydroxyethyl starch Article-31 referral - Annex I (PDF/503.73 KB)
First published: 30/11/2012
Last updated: 04/03/2013
EMA/126737/2013
Hydroxyethyl starch Article-31 referral - PRAC list of questions (PDF/79.91 KB)
First published: 30/11/2012
Last updated: 30/11/2012
EMA/PRAC/750422/2012
Hydroxyethyl starch Article-31 referral - Notification (PDF/1.04 MB)
First published: 30/11/2012
Last updated: 30/11/2012
Hydroxyethyl starch Article-31 referral - Review started (PDF/74.85 KB)
First published: 30/11/2012
Last updated: 30/11/2012
EMA/757392/2012
Recommendation provided by Pharmacovigilance Risk Assessment Committee
Hydroxyethyl starch Article-31 referral - PRAC assessment report (PDF/310.64 KB)
First published: 15/11/2013
Last updated: 15/11/2013
EMA/667674/2013
PRAC confirms that hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients (PDF/70.39 KB)
First published: 11/10/2013
Last updated: 11/10/2013
EMA/606303/2013
Recommendation to suspend marketing authorisations for hydroxyethyl starch solutions to be re-examined (PDF/69.69 KB)
First published: 12/07/2013
Last updated: 12/07/2013
EMA/349341/2013
PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl-starch (PDF/69.44 KB)
First published: 14/06/2013
Last updated: 14/06/2013
EMA/349341/2013
Position provided by CMDh
European Commission final decision
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