Hospital pharmacies will be able to deliver ADEC Uvesterol to patients who do not have an alternative in town. An RTU will be in place by the end of January.
At the end of 2016, a newborn baby died after the administration of a dose of Uvesterol D, a vitamin supplement widely prescribed to babies and children up to five years old in order to limit the risk of deficiencies.
The drug had been under surveillance for several years. In question: the pipette allowing the liquid to be delivered into the baby’s mouth, suspected of being able to induce a risk of aspiration or vagal discomfort.
Uvesterol ADEC reserved for the hospital …
As a precautionary measure, and since there are substitutes for supplementing babies with vitamin D (in particular drops), the ANSM suspended the marketing of Uvestol D on January 6, 2017. On the other hand, Uvesterol ADEC, which uses the same method of administration but the use of which is reserved for specific pathological situations for which there is no alternative is, for its part, reserved for hospital use.
In a statement released on Friday, the National Medicines Safety Agency (ANSM) specifies that this specialty is now included on List I of poisonous substances (subject to prescription), which is the most stringent. Thus, it should be prescribed and administered in hospital in premature newborns and infants at risk of vitamin A, D, E and C deficiency or malabsorption.
.. except secure outpatient access
But the ANSM adds that “due to the need, in certain situations, to continue this treatment on an outpatient basis”, it instructed, in conjunction with patient associations and learned societies concerned.es, a temporary recommendation for use (RTU) for Uvesterol VITAMIN ADEC It allows its use outside of hospitalization.
In this case, it will still be prescribed in the hospital and issued for retrocession for restricted use in children with a malabsorption syndrome (cystic fibrosis, cholestasis, intestinal insufficiency). Pending the implementation of this RTU scheduled for by the end of January, the ANSM recommends getting closer to your doctor.
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