The French drug agency has suspended the authorization of a type of treatment used in the event of massive blood loss during surgical operations, endorsing the opinion of its European counterpart, it announced on Tuesday.
“
As of October 3, 2022, hydroxyethyl starch (HEA)-based medicines can no longer be used in France
,” the National Medicines Safety Agency (ANSM) said in a statement.
These treatments, produced by the B. Braun and Fresenius Kabi laboratories, are given by infusion to patients undergoing surgery.
They are aimed at compensating for massive blood loss, increasing the volume of water in it.
But, for several years, we know that they present several risks, sometimes fatal, in particular at the level of the kidneys by which these treatments are evacuated from the body.
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The European Medicines Authority (EMA) had therefore already clearly limited their use, attaching important precautions to be observed by caregivers.
However, despite these limits, “
HES prescriptions continued not to systematically respect the contraindications and the precautions for use
”, as shown by a study commissioned by the European authorities, explained the ANSM.
As a result, the EMA decided a few months ago to completely suspend the use of these treatments, a measure now implemented by the French health authority.
"
There are alternatives to HEAs (...) which have a better benefit/risk ratio
", specified the ANSM.
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