Is fully justified the suspension of marketing of Hydroxyethyl Starch in EU?
DOI:
https://doi.org/10.30445/rear.v10i8.629Keywords:
European Union, Selling, Hydroxyethyl, Ban, prohibitionAbstract
In January 2018, EMA’s safety committee PRAC 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.
The CMDh agreed with the PRAC’s assessment of the serious risks in critically ill patients and patients with sepsis. However, the CMDh gave further consideration to the place of HES in the clinical practice of some countries, noted that previous risk minimisation measures had some effect, and considered that a combination of new risk minimisation measures would effectively ensure that HES solutions are not used in patients at risk.
References
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