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French group: Vitamin D-linked infant death not a supplement issue; Health Minister agrees

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By Shane Starling+

04-Jan-2017
Last updated on 06-Jan-2017 at 10:03 GMT2017-01-06T10:03:19Z

Uvestérol D is only available under prescription in France. A marketing suspension is underway by French authorities. ©Europe1
Uvestérol D is only available under prescription in France. A marketing suspension is underway by French authorities. ©Europe1

The French food supplements trade group Synadiet has clarified that the Uvestérol D vitamin D product linked to an infant death before Christmas was a prescription-only medicine and not available as a food supplement to the public.

French authorities are acting against the pipette-dispensed vitamin D medicine made by French firm Crinex Labs that has been blamed for the death of a 10-day old baby by choking and then cardiac arrest.

The French medical agency (ANSM) said the issue was not the substance or dosage of the products but the means of administration by pipette and the oily texture of the liquid. French Health Minister Marisol Touraine added vitamin D supplements were not in question rather “the specific way the product is administered.”

The French Health Ministry today issued a statement that a product suspension procedure was underway; that vitamin D itself was not unsafe; and suggesting caregivers contact medical professionals to recommend an ulterior mode of administering vitamin D to their infants.

Uvestérol D has previously been linked with adverse events and additional advice to caregivers was issued by the ANSM in 2006 at which point Crinex changed the pipette design to slow the flow of the liquid.

Synadiet’s scientific manager Gabrielle Ventura said the tragedy involved a product delivered under medical prescription to newborns in France.”

 

Uvestérol D how-to-use on-product instructions

She added: “Dietary supplements and other products delivering vitamin D are not supposed to be affected…Moreover, as a dietary supplement, vitamin D is recommended by the European Food Safety Authority (EFSA) for infants above the age of seven months.

“As for newborns under seven months, only medicines can be delivered, as it was the case for this 10-day-old baby.”

An ANSM spokesperson said a ‘suspension of marketing’ was underway and likely to be complete "in the next days".

RCPH: 'Vitamin D supplements are important for babies'

Dr Benjamin Jacobs of the Royal College of Paediatrics and Child Health (RCPH) in the UK, told us there were over 100 child-focused vitamin D products in the UK. 

“Side effects of vitamin D supplements are rare, and deaths are almost unheard of," said Dr Jacobs.

“We would need more information on the tragic case in France before commenting on it. But without doubt, Vitamin D supplements are important for babies in order to address poor bone health and prevent morbidities due to seizures related to vitamin D deficiency."

“We support the 2014 NICE [UK National Institute for Health and Care Excellence] recommendation and the 2016 SACN [UK Food Safety Agency's Scientific Advisory Committee on Nutrition] guidance that pregnant or breastfeeding women, and their children take supplements of 400 micrograms per day. The RCPCH is currently revising its vitamin D guidance.”

Vitamin D is typically prescribed to nutrient-deficient infants to boost bone health but deficiencies have been linked to conditions like autism and asthma.

Crinex Labs was not available for comment at the time of publication.

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