Review of hydroxyethyl-starch-containing solutions for infusion started
The European Medicines Agency has started a review of hydroxyethyl starch (HES) used for the management of hypovolaemia (low blood volume caused by dehydration or blood loss) and hypovolaemic shock (a steep fall in blood pressure caused by drop in blood volume) in critically ill patients. The review will look particularly at its use in patients with sepsis (damage to organs caused by bacteria and their toxins in the blood following an infection).
HES solutions for infusion are given by infusion (drip) into a vein and are used as volume expanders to replace lost fluids in patients with hypovolaemia to prevent shock.
Safety concerns have been raised following the publication of recent studies comparing HES with other volume expanders in critically ill patients with severe sepsis. A study comparing HES with Ringer’s acetate (another type of volume expander) in critically ill patients with severe sepsis showed that patients with severe sepsis had a higher risk of death and were more likely to receive treatment for kidney failure (such as dialysis). These results were similar to those of an earlier study. In addition, a more recent study carried out in 7,000 intensive care patients comparing HES with saline solutions (a type of volume expander called crystalloid) also showed a higher need for treatment for kidney failure in patients with sepsis but did not show an increased risk of death in hypovolaemic patients with sepsis.
The European Medicines Agency will evaluate the benefit-risk balance of HES containing solutions and issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.
More about the medicine
Infusion solutions containing HES are frequently used volume expanders and belong to the class of colloids. There are two main types of volume expanders: crystalloids and colloids. Colloids contain large molecules such as starch whereas crystalloids such as saline solutions contain smaller molecules. In the European Union (EU), HES-containing solutions for infusion have been approved via national procedures.
More about the procedure
The review of HES solutions for infusion has been initiated at the request of the German medicines agency under Article 31 of Directive 2001/83/EC.
The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations. As HES-containing medicines are all authorised nationally, the PRAC recommendation will be forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), which is a regulatory body that represents national medicines regulatory authorities of the EU Member States. This will results in harmonised measures to be implemented in all Member States.
|Name||Language||First published||Last updated|
|Solutions for infusion containing hydroxyethyl starch Article 31 referral - Review of hydroxyethyl-starch-containing solutions for infusion started||(English only)||30/11/2012|
About this medicine
|Approved name||Solutions for infusion containing hydroxyethyl starch|
|International non-proprietary name (INN) or common name|
About this procedure
|Current status||Under evaluation|
|Type||Article 31 referrals|
This type of referral is triggered when the interest of the Community 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||29/11/2012|
|Name||Language||First published||Last updated|
|Solutions for infusion containing hydroxyethyl starch Article 31 referral - Notification||EN = English||30/11/2012|
|Solutions for infusion containing hydroxyethyl starch Article 31 referral - Review of hydroxyethyl-starch-containing solutions for infusion started||EN = English||30/11/2012|
|Solutions for infusion containing hydroxyethyl starch Article 31 referral - Timetable for the procedure||EN = English||30/11/2012||21/05/2013|
|Solutions for infusion containing hydroxyethyl starch Article 31 referral - PRAC list of questions||EN = English||30/11/2012|
|Solutions for infusion containing hydroxyethyl starch Article 31 referral - Annex I||EN = English||30/11/2012||04/03/2013|
- Questions and answers - Easy-to-understand summary of the key issues and conclusions
- 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