BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

  1. Homepage
  2. Medicinal products
  3. Pharmacovigilance
  4. Risk information

Medicinal products containing hydroxyethyl starch (HES): review of the risk-benefit ratio

2016.10.18

Active substance: hydroxyethyl starch

18.10.2016 - Notice within the graduated plan procedure ("Stufenplanverfahren")

In its notice of 12 October 2016, the BfArM has ruled suspension of the marketing authorisations until 1 November 2017. This notice is not legally enforceable. It is currently permitted to place the medicinal products on the market.

16.12.2015 - Notice within the graduated plan procedure ("Stufenplanverfahren")

In a notice dated 30 September 2015, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled suspension of the marketing authorisations of medicinal products from the company Serumwerk Bernburg AG containing HES until 30 September 2016.

05.03.2014 - EU Commission's implementing decision

On 19 December 2013, the European Commission decided that solutions for infusion containing HES are only to be considered as second choice and under consideration of the new contraindications. In a ruling dated 27 February 2014, the Federal Institute for Drugs and Medical Devices (BfArM) has amended the deadline for adaptation of these texts.

28.10.2013 - PRAC recommendation

At its October meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) completed its review procedure concerning solutions for infusion containing hydroxyethyl starch.

The BfArM had already reported on this issue in the "Bulletin zur Arzneimittelsicherheit", edition 1, March 2013 (available in German only).

19.07.2013 - Procedure started (Article 107i of Directive 2001/83/EC)

The BfArM issues information on the initiation of a European safety review according to Article 107i of Directive 2001/83/EC on solutions for infusion that contain hydroxyethyl starch (HES).

25.03.2013 - Procedure started (Article 31 of Directive 2001/83/EG)

At the request of the BfArM, the European Medicines Agency (EMA) has initiated a review procedure regarding the basic evaluation of the benefit-risk balance of solutions for infusion containing hydroxyethyl starch (HES).

Further information

For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):

Hydroxyethyl starch solutions for infusion

To the risk assessment procedure (available in German only)