IPEC e-newsletter - Excipients Insight July/August 2018 - 31-08-18


Inside this issue


CMDh rules on hydroxyethyl starch solution safety

The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) – part of the Heads of Medicines Agencies – has concluded after a review that hydroxyethyl starch (HES) solutions for infusion should remain on the market.

The decision relies on the implementation of a combination of additional measures to protect patients, including training, controlled access and warnings on the packaging.

While the measures focus on the use of HES as a plasma volume expander rather than as an excipient, it is of potential interest to both users and suppliers of HES as it could have an impact on registration and supply chain for this type of medicinal product.

HES solutions for infusion are used to replace plasma volume following acute blood loss, where treatment with alternative products known as ‘crystalloids’ alone is not considered sufficient.

In January, the EMA’s safety committee recommended suspending the marketing authorisations of these medicines because they continued to be used in critically ill patients and patients with sepsis despite restrictions introduced in 2013 due to the risk of kidney injury and death in these patients.




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