The Medicines Agency will reduce the administration volumes of two baby medicines in order to reduce the risk of choking in newborns and infants.
In order to limit the risks of discomfort and of wrongdoing in newborns and infants, National Medicines Safety Agency (ANSM), will change the administration volumes of two new oral solutions used to treat vitamin deficiencies in babies. The new formulas will be available from 1Er December 2014.
New cases of discomfort
These changes respond to new reported cases of malaise and apnea in infants, due to misuse of these drugs, according to the ANSM. The false route designates the false trajectory that a food or liquid takes when ingested. The person then has difficulty breathing, turns red, and their eyes bulge. In babies, it can be fatal and can cause sudden infant death syndrome (SIDS).
Reduction of administration volumes
It is therefore to avoid these situations that Crinex laboratories, at the request of the ANSM, reduced the volumes in terms of drops of 500 IU / ml of these formulations without however modifying the doses administered. A recall of batches already marketed will be made before the new formulations are placed on the market, in order to avoid any confusion.
Advice sheets given to parents
In addition, advice sheets may be given to parents by the doctor when prescribing and by the pharmacist when dispensing the drug. They remind, among other things, to always administer the product before feeding or the bottle, to use only the dosing pipette supplied with the medication and to give the solution to the child when he is awake and installed in a semi-sitting position. In any case, the child should never be laid down immediately after administration.
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