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Alprazolam: patient information leaflet ambiguous concerning use in children

The patient information leaflet accompanying alprazolam-based anxiolytics in France mentions use in children, despite the lack of a specific evaluation for this group of patients.

In the case of one drug, the ambiguous official information has gradually evolved to allow its use in children, despite the lack of specific studies in this patient group. Alprazolam is an anxiolytic (tranquilliser) that has been available in France since 1984, with approved information specifying that it has not undergone effectiveness and adverse effects studies in subjects under 18. In 20 years, no solid clinical data on alprazolam's balance of benefits versus harm in children has appeared in the official information on this drug, but the leaflet's ambiguous wording allows it to be used now in paedriatic care. This is a reprehensible slippage whereby a pharmaceutical firm gains access to the paediatric market at the least cost, without any effort at research into the usefulness or possible risks of its drug to children.

©Prescrire October 2005

Source: "Dérapage : alprazolam chez les enfants?!" Rev Prescrire 2005 ; 25 (265) : 662.

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