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They suspend the sale in Spain of medicines for acute bleeding

Before the end of this year, three drugs against acute bleeding will be withdrawn from the market in Spain. These are Isohes, Voluven or Volulyte, the sale of which will be suspended, expected, in December 2022. This has been confirmed by the Spanish Agency for Medicines and Health Products (AEMPS) following a recommendation from the European Committee for Risk Assessment in Pharmacovigilance ( PRAC).

These drugs are hydroxyethyl-starch solutions (HEA) and after their evaluation it has been concluded that the proper use of these medications cannot be guaranteed and that the risks outweigh their benefits, which is why it was decided to withdraw them. Hydroxyethyl starch (HEA) solutions are indicated in the treatment of hypovolemia caused by acute hemorrhage when treatment with crystalloids alone is not considered sufficient.

Starting in December 2022, Isohes, Voluven or Volulyte cannot be used or sold in Spain, as will be the case in all EU countries, in accordance with the Decision of the European Commission (EC) published on May 24 following the recommendation of the European Committee for Risk Assessment in Pharmacovigilance (PRAC). However, it is established that, on an exceptional basis, Member States may postpone said suspension for a period not exceeding 18 months from the date of the decision.

However, the AEMPS considers it necessary to establish a period so that health centers that currently use these medications can adapt their protocols to said suspension, considering other therapeutic alternatives. Therefore, the suspension of marketing will become effective in Spain in a few months. The AEMPS will inform in advance of the effective date. Until that date, these medications must be used in strict accordance with the current authorized conditions of use, including the controlled access program for HEA solutions.

The benefit/risk balance of HEA solutions has been reviewed on several occasions and in 2018 a series of risk minimization measures were imposed, including a program of controlled access to HEA solutions to remind contraindications in critically ill patients. , with sepsis or in patients with kidney damage, and a study to evaluate the use of HEA under the authorized conditions of use.

In February 2022, the PRAC reviewed the results of this study, concluding that the restrictions introduced in 2018 failed to ensure the appropriate use of these medicines. Consequently, and considering that the risks related to the use of HEA outweigh its benefits, the PRAC recommended the suspension of the marketing authorization in the EU, a measure that will finally come into force this year as reported by the AEMPS.