The minister of health, Marisol Touraine, announced that the procedure had been triggered ” as a precaution “. The death of a new-born, on the 21st of December, had been revealed Monday.
A procedure for the suspension of the marketing of the Uvestérol D was initiated after the death of an infant, announced, Wednesday, January 4 in a press release, the minister of health, Marisol Touraine.
” The findings of investigations available to date highlight a probable link between the deaths and the administration of the Uvestérol D “, has explained, in a separate release, the national security Agency of medicines and health products (MSNA). the ” Also, in spite of the risk reduction measures put in place since 2006, to secure the administration and the strengthening of the recommendations, the MSNA launches, as a precautionary measure, a contradictory procedure with the laboratory in view of the suspension of the marketing of its specialty Uvestérol D, in the coming days, “, the agency says.
An infant aged ten days, died on the 21st of December after having received a dose of Uvestérol D, a drug that is very commonly used against the deficiency of vitamin D. pending the final decision of the MAN on the medicine, Marisol Touraine ” call, as a precautionary measure, the parents no longer administer of Uvestérol D to their children “.
” Only the Uvestérol D is affected by this procedure “
” I wish to reassure the parents that have given of vitamin D, in any form whatsoever, to their children : they will not be harmed “, said Mme Touraine, stating :
” Only the Uvestérol D is concerned in this process, not the other specialities of vitamin D. “
” It is the mode of administration, specific to the product that presents risk [and non-vitamin D] “, emphasizes the minister. Vitamin D is essential for the development of infants, it ” called for the families to get closer to their health care professional, which provide vitamin D in another form “. the ” I guaranteed a information that is transparent, objective and reliable. And I propose, in connection with the health professionals, as an alternative solution. “
” The recommendations for health professionals will be addressed in the day “, provided Mme Touraine, who will set up ” in the morning with a toll free number information, phone 0800-636-636 “.
Malaise vagal
the death of The infant was not immediately made public. It was revealed on Monday by Le Figaro. According to the newspaper, the Director-general of health, Benoît Vallet, had been informed of the death on the same day, as the MAN, who would have learned a ” informally “, but would not have asked for more information that on the 27th of December.
For eleven years, responsible for pharmacovigilance have regularly questioned the relevance of leaving it on the market, a prescription for which a dozen cases of malaise vagal or wrong food are reported each year. They have repeatedly called for a suspension of the Uvestérol.
In its press release published Monday, the MAN explained himself to be brought to the court since 2006 : ” After the finding of adverse effects related to its administration, the Uvestérol D since 2006 strengthened oversight of the health authorities, (…). Measures of risk reduction have been put in place. “
Precautions
to Give vitamin D to counterbalance the frequent deficiency of this substance essential for the growth and consolidation of bone is a routine practice. Several forms of vitamin D are available, but the Uvestérol D (laboratories Crinex) has the form of an oily solution, which requires some precautions. After several discomforts in 2006, the MAN had reminded healthcare professionals to carefully follow the protocols of administration, and the manufacturer had changed the dropper to avoid too rapid administration.
new formulations and presentations of Uvestérol had been made available by the laboratories Crinex in November 2014, in response to the requests of the MSNA, in particular by reducing the volume to be administer by increasing the concentration of the solution and by modifying accordingly the graduated pipettes.
The Commission nationale de pharmacovigilance (CNPV) has again reviewed the case in July 2016, but the record of this meeting has still not been made public. After learning of the death of the infant at the end of December, the heads of several regional centres of pharmacovigilance had requested the suspension of the placing on the market of the Uvestérol.
Read also : An infant died after an intake of vitamin D
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