January 2018 PRAC - conclusion of the new reassessment of drip solutions containing hydroxyethyl starch (HES)

During its meeting of January 2018, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) concluded the new reassessment of drip solutions containing hydroxyethyl starch (HES) that began in October 2017. The PRAC recommends suspending their marketing authorisations (MA).

The PRAC recommends the suspension of marketing authorisations for drip solutions containing hydroxyethyl starch (HES) in the European Union. These medicinal products are used to replace plasma volume following a significant, unexpected blood loss where a single treatment with alternative drip solutions, known as “crystalloids”, is considered insufficient.

The reassessment was triggered following the results of two drug utilisation studies (DUS) which indicated that HES solutions were still being used with seriously ill patients and those suffering from septicaemia and renal damage, despite restrictions introduced in 2013 to reduce the risk of kidney problems and death with these populations.

In 2013, the PRAC recommended restrictions on the use of HES solutions, including the restriction to no longer use them in the treatment of seriously ill patients or those suffering from septicaemia, due to an increased risk of renal damage and mortality observed during the clinical trials. The PRAC had requested that additional studies be performed to ensure these restrictions were being respected.

The PRAC has assessed the results of the DUS on HES drip solutions, as well as data currently available on the benefits and risks resulting from the clinical trials and observational studies, in addition to the feedback received from partners and experts. Based on this assessment, the PRAC has concluded that the restrictions introduced in 2013 have not been sufficiently effective. The PRAC has explored the possibility of introducing additional measures, but it has concluded that such measures would be ineffective or insufficient.

In view of the serious risks to which certain patient populations are exposed, the PRAC is recommending the suspension of marketing authorisations for HES solutions. Alternative treatment options are available.

The PRAC’s recommendation of January 2018 will now be passed on to the Coordination Group for Mutual Recognition and Decentralised Procedures - human (CMDh) for examination during their meeting held between the 22nd and 25th January 2018.

In Belgium, medicinal products containing HES are available under the following commercial names: HAES-STERIL, PLASMA VOLUME REDIBAG, TETRASPAN, VENOHES, VOLULYTE and VOLUVEN.

More information is available on the EMA website.

Last updated on