Berlin

New safety warnings issued for infant vitamin D and fluoride tablets

When tablets containing colecalciferol (vitamin D3) and fluoride are used to prevent rickets and/or tooth decay in infants and young children, it is essential to ensure they fully disintegrate before administration. Germany's Federal Institute for Drugs and Medical Devices (BfArM) has reported the death of an infant in which a suspected case of foreign-body aspiration occurred after an undissolved tablet was administered.

An infant was given a vitamin D/fluoride supplement for rickets and/or tooth decay prevention and died shortly after taking the tablet. The fatal incident is believed to have resulted from aspiration caused by the tablet failing to dissolve completely.

To prevent complications, tablets containing both vitamin D and fluoride must never be given to infants or young children in undissolved form. Before administration, it must be confirmed that the tablet has fully disintegrated. According to the product information, these tablets should be dissolved in water, milk, or breast milk, as other liquids may impair or delay the dissolution process.

Parents and caregivers should be properly informed about this risk when receiving the medication. Additionally, when switching between different products, the specific instructions in the respective product information must be followed.

Combined rickets and tooth decay prevention with these supplements is recommended for infants and children up to 18 months of age if the fluoride concentration in drinking or mineral water is below 0.3 mg/L and no additional fluoride is being consumed.

The tablets can be dissolved on a teaspoon or in a small transparent container with approximately 5 to 10 mL of water. Dissolution may take one to two minutes, and gently stirring the spoon can help speed up the process. The dissolved tablet should be administered directly to the child, preferably during a meal.

The optimal time for administration is in the evening after brushing teeth, as this allows higher fluoride concentrations to remain on the teeth for longer.

If the tablet is dissolved in a bottle or mixed with pureed food, care must be taken to ensure the child consumes the entire portion to receive the full dose of the active ingredients.