title: [Eyedrops in children and pregnant or breast-feeding woman: why so many difficulties?].
abstract: The use of eye drops in a child or a pregnant or a breast-feeding woman is often difficult, since clearly established license and scientific data are rare. These two difficulties are related. Indeed, clinical research programs exceptionally include children or pregnant/breastfeeding women, except when the product is directly intended for these populations, unusual in ophthalmology. As a consequence, the scientific publications give very little information on the balance between benefit and risk in these patients. Legal authorities therefore cannot base authorization decisions on robust data or on the contrary clearly mention the danger of many ophthalmic solutions. For that reason, the summaries of the characteristics of the product most often include precautionary recommendations, in practice a rejection, even when the empirical clinical practice suggests their possible use. The analysis of these difficulties underlines the importance of conducting clinical trials including this type of patient or, failing that, the necessity of consensus conferences to facilitate physicians' daily medical practice.
authors.affiliation: Service d'Ophtalmologie, Centre Hospitalier Universitaire Bicêtre, Le Kremlin-Bicêtre, France. marc.labetoulle@bct.aphp.fr
authors.forename: M
authors.initials: M
authors.lastname: Labetoulle
authors.forename: G
authors.initials: G
authors.lastname: Gendron
authors.forename: H
authors.initials: H
authors.lastname: Offret
mesh_terms: D000293:Adolescent; D001942:Breast Feeding; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D009883:Ophthalmic Solutions / Q000493:pharmacokinetics; D011247:Pregnancy
chemical_list: D009883:Ophthalmic Solutions