FRANCE HAS MOVED to suspend sales of a vitamin D medication following the death of a baby who suffocated after being given the liquid supplement, health authorities said today.
France’s ANSM agency that oversees the safety of medicines and health products said it had taken the measure “as a precaution” after investigations showed “a probable link between the death and the administration of Uvesterol D”.
The 10-day-old baby died on 21 December after being given Uvesterol D, a popular brand of drops prescribed for children suffering from vitamin D deficiency. The supplement is only available in France.
ANSM has previously issued warnings about how the supplement is administered – with a pipette – following cases of respiratory problems, especially among premature babies and newborns.
The agency said it would suspend the marketing of Uvesterol D in the coming days.
Uvesterol D is made by Crinex, a French pharmaceutical company.
Health Minister Marisol Touraine said it was “the specific way the product is administered that presents risks”, rather than the vitamin itself.
In advance of a definitive decision from ANSM, she called on parents, “as a precautionary measure, to no longer administer Uvesterol D to their children”.
“I want to reassure parents who have given vitamin D, in whatever form, to their children: they are safe,” she said in a statement today, adding that “only Uvesterol D is concerned” by this procedure.
In an email on 30 December and seen by AFP, ANSM said the baby died at home from “cardio-respiratory arrest” after receiving a dose of Uvesterol D.
The child showed “signs of suffocation” directly after receiving the product, two hours after breastfeeding, the ANSM wrote.
Uvesterol D comes in a vial from which the dose is extracted with the pipette.
In 2006 and again in 2013, the ANSM had issued precautions to be taken when administering the supplement, to avoid babies choking on the fluid.
Parents were advised, among other things, to give it to babies “drop by drop”.
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