After the death of a 10-day-old baby, the Medicines Agency initiated a procedure to suspend the marketing of this vitamin D as a precautionary measure.
Nearly two weeks after the death of a 10-day-old infant, the National Medicines Safety Agency (ANSM) initiated a procedure to suspend the marketing of Uvesterol D, a vitamin D-based medicine. The announcement was made early Wednesday January 5 by the health authority and the Minister of Health.
“The conclusions of the investigations available to date highlight a probable link between death and the administration of Uvestérol D,” explains the ANSM in a press release. Also, despite the risk reduction measures put in place since 2006 to secure the administration and reinforce the recommendations, the ANSM is launching, as a precautionary measure, an adversarial procedure with the laboratory with a view to suspending the marketing. of its specialty Uvestérol D, in the coming days ”, we can read in the press release.
The 10-day-old newborn baby died on December 21 from cardio-respiratory arrest after receiving a dose of Uvesterol D, a drug given to children to prevent or treat vitamin D deficiencies. For 10 years, this oral solution Oily administered by pipette is the subject of increased surveillance because it is responsible for several cases of vagal discomfort in infants, especially premature babies and babies under one month, related to the method of administration of the drug.
Setting up a toll free number
The Minister of Health Marisol Touraine thus recalls that it is not the drug which is called into question but its mode of administration by pipette. “I want to reassure parents who have given vitamin D in any form to their children that they are not in danger,” she said. But I ask them, as a precaution, to stop treatment with Uvesterol D. “
An opinion shared by Dr François-Marie Caron, pediatrician at the University Hospital of Amiens interviewed by Why actor. He indicated that this treatment could very easily be replaced by another vitamin D administered in the form of drops. He invites parents to stop Uvesterol D and approach their pediatrician or general practitioner to obtain another vitamin D. Because “only Uvesterol D is concerned by this procedure, not other specialties based on vitamin D”, insists the ministry.
In addition, Marisol Touraine wanted to strengthen the information provided to families by activating a toll-free number on 0800 636 636.
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