Countdown so that medicines based on hydroxyethyl-starch (HEA) solutions are no longer available in Spanish pharmacies. The next Thursday December 15 will cease to be distributed in accordance with the notice of the Spanish Agency for Medicines and Health Products (Aemps).
Specifically, the drugs that will no longer be available are Isohes, Voluyte and Voluvenbelonging to the group of plasma volume substitutes, used to restore blood volume caused by bleeding when treatment with crystalloids alone is not considered sufficient.
As reported by the Spanish Agency for Medicines and Health Products (Aemps), the stocks available in health centers may be returned to the incumbent laboratories “through the usual channels.”
The measure corresponds to a recommendation of the European Medicines Agency (EMA) agreed after the one carried out by the European Pharmacovigilance Risk Assessment Committee (PRAC).
Reasons behind withdrawal
The PRAC resolution determined that the restrictions introduced in 2018 for the correct use of this group of medicines were not satisfactory. The balance between the benefits and risks of the drugs remains unbalanced, which is why HEA solutions were discontinued.
The association of these drugs with certain conditions, relating to kidney function, had begun to seriously worry the experts. Thus, in 2018 it was recommended that it only be used for the treatment of hypovolemia (decrease in usual blood volume) caused by acute bleeding, as long as it was not in patients with sepsis, renal failure or in a critical situation.
The measure adopted by the Ministry of Health is also the one that must be adopted by other neighboring countries. “The marketing authorization must be suspended in all EU countries,” the Spanish agency has ruled, recalling that the PRAC recommendation was ratified by the European Commission, which published the corresponding decision on May 24.
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