Fears over vitamin D medicine for kids after ‘newborn baby SUFFOCATES just hours after being given supplement in France’
French authorities move to suspend sale of Uvesterol D, made by French company Crinex, amid safety concerns
FEARS are growing over a vitamin D medicine for kids following the death of a baby who suffocated just hours after being given the supplement in France.
The 10-day-old baby died on December 21 after being given Uvesterol D, a popular brand of drops prescribed for children suffering from vitamin D deficiency.
In an email sent on December 30, France's ANSM agency – which is in charge of ensuring the safety of medicines and health products – said the baby died at home from "cardio-respiratory arrest" after receiving a dose of the supplement.
The child showed "signs of suffocation" directly after being given the product, two hours after breastfeeding, the agency wrote.
France has now moved to suspend sales of supplement "as a precaution" after investigations showed "a probable link between the death and the administration of Uvesterol D".
The ANSM announced the move today, saying sales would be halted in the coming days.
The agency has previously warned about how the supplement is administered – using a pipette – has after reports of respiratory problems, particularly in premature babies and newborns.
Health Minister Marisol Touraine confirmed this, saying it was "the specific way the product is administered that presents risks", rather than the vitamin itself.
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Uvesterol D, which is only available in France, comes in a vial from which the dose is extracted with the pipette.
In 2006 and again in 2013, the ANSM had advised 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".
While ANSM officials debate the final verdict on Uvesterol D – made by French pharmaceutical company Crinex – Touraine 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," Touraine said in a statement Wednesday, adding that "only Uvesterol D is concerned" by this procedure.
Crinex expressed its “compassion for the parents” and offered its full support to authorities in their investigation.
Philippe Paulmier, pharmacist manager at the Crinex laboratory, said: “The death of a newborn is a tragic event and we can only feel the pain of the parents.
“It has been 25 years that we have been selling this product and ten million children were treated with Uvestérol D, with no deaths reported.”
Crinex also pointed to a detailed set of instructions which the firm had issued for the administration of the drug, including sitting the child up and not laying them flat during or soon after giving them the medicine.
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