The National Medicines Agency has decided to suspend the marketing of Uvesterol D, a drug against vitamin D deficiency whose method of administration by pipette is suspected to be the cause of the death of a new patient. born shortly before Christmas.
A procedure for suspending the marketing of Uvesterol D was initiated after the death of an infant, the Minister of Health, Marisol Touraine announced in a press release on Wednesday January 4.“The conclusions of the investigations available to date highlight a probable link between death and the administration of Uvesterol D”, announced the same day in a separate press release the National Agency for the Safety of Medicines and Health Products. The ANSM specifies that it is launching “As a precaution” an adversarial procedure with the laboratory “With a view to the suspension of the marketing of its specialty Uvestérol D, in the coming days”.
A ten-day-old infant died on December 21 after receiving a dose of Uvesterol D, a very common drug used for vitamin D deficiency.
Ms. Touraine calls on parents to stop administering Uvestérol D to their children
Pending the final decision of the ANSM on the drug, the Minister of Health Marisol Touraine called for his part “parents to no longer administer Uvesterol D to their children ”. “I want to reassure parents who have given vitamin D, in any form whatsoever, to their children: they are in no danger”, adds the Minister in a press release, specifying that “only Uvesterol D is concerned by this procedure, not other specialties based on vitamin D”.“But I ask them, as a precaution, to stop treatment with Uvesterol D”, she continues, assuring parents that she puts “Doing everything possible to offer them, in conjunction with healthcare professionals, an alternative solution”.
The ten-day-old infant died at home from “cardio-respiratory arrest” after receiving a dose of Uvesterol D, according to the ANSM. The child presented “Signs of suffocation” “Immediately after administration” of the product, “two hours after feeding ”, detailed the ANSM in an email sent on December 30 to the regional pharmacovigilance centers, of which AFP has obtained a copy. No details were given on the time between suffocation and cardiopulmonary arrest.
The minister pointed out on Wednesday that “It is the specific mode of administration of the product that presents risks (and not vitamin D)”.
Several serious incidents have occurred
Several serious incidents (discomfort with apnea, “false routes”, etc.) have been reported in the past, linked to the method of administration with the pipette, being equivalent to the product. “Enhanced surveillance” since 2006, recalled the ANSM.
In 2006, then again in 2013, the agency warned about the precautions to be taken in infants: “Always administer the product before feeding or bottle-feeding ”, install the child “Awake” “in a semi-sitting position”, leave the child “Suck” syringe or pour the product “drip ”, do not lengthen it “Immediately after administration”, warns the notice.
The laboratory also reformulated the product in 2014, which is now more concentrated so that the volume to be administered is smaller (0.2 ml, or four drops, against 1 ml previously). Gold, “There is no tangible evidence of evaluation showing that these changes reduce the risk of discomfort” noted in 2015 the medical journal Prescrire after having, in 2014, deplored the lack of “serious management of the problem”.
Reacting to AFP, Socialist deputy specializing in public health issues, Gérard Bapt, called the agency “To suspend the prescription” and said to himself “Stunned by the lack of responsiveness and transparency” of the ANSM.
An information toll-free number has been created
Since vitamin D is essential for the development of infants, the minister called families on Wednesday “to get closer to their healthcare professional, who will offer them vitamin D in another form ”. The Minister specifies that the recommendations for health professionals will be theirs “Addressed during the day” and announces the establishment “in the morning” a toll-free information number: 0800 636 636.
Uvesterol D is a very common vitamin D-based drug, produced by the French laboratory Crinex. It is in liquid form, in a vial from which the dose to be administered is extracted using a pipette.