Unsuitable, the measuring pipette of this syrup exposes children to an iron overdose

In a letter intended for pharmacists, pediatricians and general practitioners, the Medicines Agency warns of the risks of overdose and medication error associated with Ferrotrane syrup 0.68% “particularly in low-weight newborns and infants”. “Particular attention must be paid to the prescribed volume” asks the authority. In question, “the measuring pipette provided in the box does not allow the correct dosage to be administered for the little ones: it has graduations from 0.5 to 0.5 mLwhile in some situations the prescribed dosage is not a multiple of 0.5 mL (e.g. 0.3 mL, 0.7 mL or 1.3 mL per day)” specifies theANSM. Ferrostrane 0.68% syrup (sodium feredetate) is indicated for low weight babies in curative or preventive treatment of iron deficiency. It is also more widely prescribed to prevent iron deficiency in pregnant women and in cases of iron deficiency anemia. in adults.

Monitor the occurrence of digestive disorders

An iron overdose can cause digestive disorders such as diarrhea, constipation, nausea, vomiting, or even digestive bleeding. In infants, these adverse effects may be particularly severe.

A new adapted presentation for infants is currently being developed, with a dosing pipette with finer graduations, suitable for very small volumes to be administered. She should be provision“during the second half of 2024“. In the meantime, the medicines agency is asking doctors and pharmacists toindicate the volume to administer “clearly on prescription (xx mL/day)”. If the volume cannot be taken with the pipette provided in the box, the pharmacist and/or prescriber must raise awareness among parents on the risks of over/under-dosing and the best way to collect the right volume of medicine.