How safe is vitamin D? France to BAN supplement after baby dies FRANCE is to ban a brand of vitamin D following the death of a 10-day-old baby - sparking worldwide concerns the supplement could be unsafe. GETTYThe young child had been given a dose of Uvesterol D, which is commonly used to prevent and treatment vitamin D deficiency in newborns.But the baby later died on December 21 after suffering a devastating cardio-respiratory attack.A statement from French agency ANSM said: “The conclusions of investigations so far show evidence pointing to a probable link between the death, and the dose of Uvesterol D that was administered.”Now the brand, which is manufactured by the Crinex Laboratory, could be suspended from sale following an investigation.GETTYHealth Minister Marisol Touraine said: “I want to reassure parents who have given vitamin D, in any form whatsoever, to their children: They are safe.”She called on parents not to give their child supplements of the particular brand, but promised other substitutes are fine to use.
The minister also committed to share “transparent, objective and reliable information” on the product as more data becomes available. 10 common health myths Here are 10 common health myths that most people think are true. Common health myths and old wives' tales I want to reassure parents who have given vitamin D, in any form whatsoever, to their children: They are safe The suspension will come into effect in the next few days, and will only cover Uvesterol D administered with a pipette.ANSM insisted the suspension was only a “precautionary measure” and confirmed other vitamin D products were still safe to use.The agency had previously issued warnings about how the supplement was administered following a series of cases among infants, newborns under one month old, as well as premature babies.GETTYThe brand had also been under surveillance since 2006, due to several reports of problems including choking and apnea.Corinne made the product more concentrated in 2014 and reduced the dosage, but a review found no indication that the risk to children was reduced.
Now the temporary ban on the product has sparked concerns across the globe about the safety of Vitamin D products.GETTYHowever, the UK's Department of Health recommends that children aged from six months to five years are given daily supplements - including vitamin D.Dr Benjamin Jacobs of the Royal College of Paediatrics and Child Health in the UK said there were more than 100 products on the market used for young children - and that “side effects of vitamin D supplements are rare”.Vitamin D, which helps address poor bone health, has previously been associated with conditions such as autism and asthma.Vitamin D supplement suspended in France following death of newborn France has taken action to suspend the sale of a vitamin D supplement, Uvesterol D, following the death of a 10-day old baby who died on 21 December after being administered a dose of the supplement – a popular brand of vitamin D supplement which is only available in France, and is widely prescribed for treatment of vitamin D deficiency amongst young children in the country.
According to the national medical safety agency (ANSM), “only Uvesterol D administered with a pipette is involved” in this move. Alerts against Uvesterol D were previously raised The newborn was allegedly given a dose of the oral liquid supplement, administered via a plastic pipette. Immediately after, the baby reportedly showed signs of suffocation and died from a cardio-respiratory arrest two hours later. According to the national medical safety agency (ANSM), it had previously issued warnings on the method of administration of Uvesterol D after several cases of serious illness were documented, particularly among premature newborns and babies under the age of one month. The agency added that in 2006, measures were imposed to reduce risks from taking Uvesterol D, and Crinex, the producer of Uvesterol D, changed the pipette to prevent the oily liquid supplement – which has been cited by the French daily Le Monde to being different from other forms of liquid vitamin D – from being administered too quickly.
In 2013, the ANSM then issued warnings to parents, urging them to reduce the recommended dosage and administer the supplement in a drop-by-drop manner with the baby in a semi-sitting position, before he or she has fed. However, there had been no reports of mortality caused by consumption of Uvesterol D since it was made available in the market in 1990, until December. Newborn’s death likely due to method of administration While the country’s medical safety agency posited a “probable link” of the newborn’s death to the particular supplement, Health Minister Marisol Touraine said that “it is the specific way the product is administered that presents risks,” adding that the danger was not by consuming vitamin D supplements in general. As a precautionary measure, Touraine has urged parents 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, further adding that “only Uvesterol D is concerned” in this matter.
Severely dehydrated British child sucked on wet wipes and died, NHS issues apology HSA bans three "health products" after woman is hospitalised in Singapore Is overprescribing for the benefit of doctors or their patients?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".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.”