The European Medicines Agency (EMA) recommends suspending the marketing of hydroxyethyl-starch medicines in the European Union (EU).
Its use kidney damage and death
The entity warns of its serious risks in certain patients. It points to kidney damage and death in those who are very ill or who have a severe generalized infection or kidney damage.
In 2013, solutions for infusion of this medication were reviewed in two procedures. A series of restrictions and measures were also carried out to minimize the risk of kidney damage and death in certain patients (critically ill, with burns or sepsis, that is, a bacterial disease). They were launched at that time ”, details the EMA.
Additionally, more warnings were introduced in the information of these medicines to remind health professionals that they should not be used in critically ill patients, with sepsis or in patients with kidney damage. It was also established that the Marketing Authorization Holders (MAH) of HES solutions carry out a study to assess the use of HES and compliance with the authorized conditions of use.
In 2018 some restrictions had already been added
Subsequently, in 2018, restrictions were added which, according to the committee, “have not sufficiently guaranteed that these drugs are used safely.” And that “they continue to be used in certain groups of patients in which serious damage has been demonstrated.”
What is Hydroxyethyl-starch?
Hydroxyethyl-starch is a “colloidal plasma expander, indicated for the treatment of hypovolemia caused by acute hemorrhage when treatment with crystalloids alone is not considered sufficient”, according to the Spanish Agency for Medicines and Health Products. This medicine is used for those patients who have lost blood after an injury or surgery.
After the reports made throughout these years, the European Committee for the Evaluation of Risks in Pharmacovigilance (PRAC). It has recommended the suspension of its marketing, and has assessed new risk minimization measures.
The PRAC has also reassessed possible additional risk minimization measures. But it has concluded that “there are no other viable measures that can be considered sufficient to protect patients.”
There are other treatment options available for these patients.
The PRAC recommendation will be sent to the European Coordination Group for Mutual Recognition and Decentralized Procedures (CMDh). For ratification at its next meeting in February 2022. In any case, and in the meantime, the European regulatory body has reported that there are other treatment options available for these patients.
“The committee has concluded that the restrictions introduced in 2018 have not sufficiently ensured that these drugs are used safely. And that they continue to be used in certain groups of patients in which serious damage has been demonstrated, ”adds the AEMPS.
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