Autorisation de mise sur le marché et information pédiatrique pour les médicaments de chimiothérapie des cancers: État des lieux et propositions

C. Thouvenel, M. S. Gény, S. Demirdjian, G. Vassal

    Résultats de recherche: Contribution à un journalArticleRevue par des pairs

    11 Citations (Scopus)

    Résumé

    Paediatric medicines are often prescribed off label because appropriate clinical and pharmacological studies have not been conducted in children. A European directive is being written to promote the development of paediatric medicines through incentives to pharmaceutical companies, as is already the case in the US. Method. - In order to evaluate the status of anticancer drugs, we analyzed the paediatric information available in the Vidal® 2000 dictionary for cytotoxic chemotherapy. Results. - Among the 76 products, 48 were currently used to treat children with cancer. An indication for paediatric use was described in only 29% of them. Paediatric use was mentioned in the posology chapter in 56% of cases, and in the warning or contra-indication chapter in 17% of cases. Ten products (21%) were devoid of paediatric information. Discussion. - The paucity of this official paediatric information contrasts with the number of clinical and pharmacological studies that have been conducted and published by paediatric oncology societies and groups. Indeed, almost 80% of children with cancer are treated using prospective therapeutic research protocols. In conclusion, anticancer medicines have been evaluated in children, but official paediatric information is poor. This situation can be significantly improved with the literature currently available. On the other hand, prospective clinical studies are needed to better define the optimal dose in children under one year of age, to evaluate long-term sequelae in cured patients and to provide appropriate galenic forms for oral chemotherapy. Conclusion. - Incentives are urgently needed to facilitate access to therapeutic innovations in oncology and their development in children with cancer.

    Titre traduit de la contributionStatutory pediatric informations available for anticancer drugs: Inventory and proposals
    langue originaleFrançais
    Pages (de - à)685-693
    Nombre de pages9
    journalArchives de Pediatrie
    Volume9
    Numéro de publication7
    Les DOIs
    étatPublié - 1 janv. 2002

    mots-clés

    • Cancer
    • Chemotherapy
    • Child
    • Drug approval
    • Drug information services

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