This drug is very common, vitamin D, produced by the laboratoire Crinex, has been the subject of several warnings in the past after the discomforts of babies during his administration.“The investigations are underway to determine the exact cause of death and whether it is likely to be attributed to the Uvestérol D”, pointed out to the MSNA, in a news release. the “Since 1990, the date of the placing on the market of the uvestérol D, no deaths have been attributed to the administration of this product”, emphasizes the agency of the drug.
The question of the suspension of this medicine is administered
The child who died at the end of December, at the age of ten days, “has shown signs of choking and cardio-respiratory arrest prior to being transported” at the Cochin hospital in Paris, according to le Figaro, saying that the question of the suspension of this medicine, placed under surveillance since 2006, is being asked. According to the newspaper, the MAN was informed of the death the same day that “informally” and was asked last Tuesday, “more information” in Cochin.
Friday, “eight days after the accident,”, the MAN alerted the centers of pharmacovigilance (CRPV) are responsible for ensuring that the side-effects of health products. The drug agency provides to be “in close link with the regional centres of pharmacovigilance concerned since the 22nd of December”. The first conclusions of the investigations will be known in the coming days”. They will enable the implementation of measures that prove to be necessary,” adds the MSNA.
The MAN had been part of the precautions to be taken at the end of 2013
After the first warnings in 2006, the ASNM had reiterated at the end of 2013 the precautions when taking this medicine, indicated to prevent vitamin-D deficiency, especially among infants and children up to 5 years, in order to prevent the “false paths”.
The agency had been state “reports of discomfort and the wrong way in infants, especially in premature newborns and infants less than one month” and indicated that they have asked the laboratory Crinex to put in place “the measures of minimisation of risks”. These measures included the delivery of guidance sheets for parents by the doctor or pharmacist on how to administer the medication.
on several occasions, the independent review Prescribing has drawn attention to the risks related to the mode of administration of this drug, by means of a pipette dispenser. In an article published in 2014, it was estimated that the MAN and the company Crinex “did not show support for a serious problem.”
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