For infants suffering from atopic eczema (also known as atopic dermatitis), if eliminating irritation factors and the use of emollients (“skin softeners”) prove insufficient, a low-strength topical corticosteroid (such as 1% hydrocortisone) often relieves outbreaks. Moderately potent and in particular potent topical corticosteroids should be avoided as much as possible in infants.
And yet, fluticasone has been authorised for infants over 3 months and no longer from the age of one year, with no reference to the severity of the symptoms or to the failure of previous treatments.
Fluticasone is the only potent topical corticosteroid commercialised in France for which the Summary of Product Characteristics approved by the drug regulatory agency explicitly mentions use in infants.
However clinical evaluation is extremely incomplete. It does not make it clear whether fluticasone is more effective than a less potent topical corticosteroid, nor does it identify the risks in young infants, who are particularly exposed to the systemic adverse effects of topical corticosteroids, due to their very extensive body surface in relation to their weight, and to the presence of numerous skin folds (from which topical corticosteroids pass more easily into the bloodstream).
The packaging is not suitable to ensure correct control of the amount used.
It is unacceptable that the authorities have not been more stringent with regard to the firm and do not put the infant’s best interests first.
It is up to healthcare professionals to explain to parents how to use the less potent topical corticosteroids wisely, and to avoid trivialising them.
©Prescrire 1 July 2012
"Topical fluticasone for infants from 3 months of age" Prescrire Int 2012; 21 (129): 179. (Pdf, subscribers only).