Cargando…

Stimulation programs for pediatric drug research – do children really benefit?

Most drugs that are currently prescribed in pediatrics have not been tested in children. Pediatric drug studies are stimulated in the USA by the pediatric exclusivity provision under the Food and Drug Administration Modernization Act (FDAMA) that grants patent extensions when pediatric labeling is p...

Descripción completa

Detalles Bibliográficos
Autores principales: Boots, Isabelle, Sukhai, Rám N., Klein, Richard H., Holl, Robert A., Wit, Jan M., Cohen, Adam F., Burggraaf, Jacobus
Formato: Texto
Lenguaje:English
Publicado: Springer-Verlag 2007
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1914295/
https://www.ncbi.nlm.nih.gov/pubmed/17225950
http://dx.doi.org/10.1007/s00431-006-0381-z
_version_ 1782134123053187072
author Boots, Isabelle
Sukhai, Rám N.
Klein, Richard H.
Holl, Robert A.
Wit, Jan M.
Cohen, Adam F.
Burggraaf, Jacobus
author_facet Boots, Isabelle
Sukhai, Rám N.
Klein, Richard H.
Holl, Robert A.
Wit, Jan M.
Cohen, Adam F.
Burggraaf, Jacobus
author_sort Boots, Isabelle
collection PubMed
description Most drugs that are currently prescribed in pediatrics have not been tested in children. Pediatric drug studies are stimulated in the USA by the pediatric exclusivity provision under the Food and Drug Administration Modernization Act (FDAMA) that grants patent extensions when pediatric labeling is provided. We investigated the effectiveness of these programs in stimulating drug research in children, thereby increasing the evidence for safe and effective drug use in the pediatric population. All drugs granted pediatric exclusivity under the FDAMA were analyzed by studying the relevant summaries of medical and clinical pharmacology reviews of the pediatric studies or, if these were unavailable, the labeling information as provided by the manufacturer. A systematic search of the literature was performed to identify drug utilization patterns in children. From July 1998 to August 2006, 135 drug entities were granted pediatric exclusivity. Most frequent drug groups were anti-depressants and mood stabilizers, ACE inhibitors, lipid-lowering preparations, HIV antivirals, and non-steroidal anti-inflammatory and anti-rheumatic drugs. The distribution of the different drugs closely matched the distribution of these drugs over the adult market, and not the drug utilization by children. Many drug studies in children have been performed since the introduction of the FDAMA. However, children infrequently use the drugs granted pediatric exclusivity. The priorities for pediatric drug research should be set by the need of the patients, not by market considerations.
format Text
id pubmed-1914295
institution National Center for Biotechnology Information
language English
publishDate 2007
publisher Springer-Verlag
record_format MEDLINE/PubMed
spelling pubmed-19142952007-07-12 Stimulation programs for pediatric drug research – do children really benefit? Boots, Isabelle Sukhai, Rám N. Klein, Richard H. Holl, Robert A. Wit, Jan M. Cohen, Adam F. Burggraaf, Jacobus Eur J Pediatr Original Paper Most drugs that are currently prescribed in pediatrics have not been tested in children. Pediatric drug studies are stimulated in the USA by the pediatric exclusivity provision under the Food and Drug Administration Modernization Act (FDAMA) that grants patent extensions when pediatric labeling is provided. We investigated the effectiveness of these programs in stimulating drug research in children, thereby increasing the evidence for safe and effective drug use in the pediatric population. All drugs granted pediatric exclusivity under the FDAMA were analyzed by studying the relevant summaries of medical and clinical pharmacology reviews of the pediatric studies or, if these were unavailable, the labeling information as provided by the manufacturer. A systematic search of the literature was performed to identify drug utilization patterns in children. From July 1998 to August 2006, 135 drug entities were granted pediatric exclusivity. Most frequent drug groups were anti-depressants and mood stabilizers, ACE inhibitors, lipid-lowering preparations, HIV antivirals, and non-steroidal anti-inflammatory and anti-rheumatic drugs. The distribution of the different drugs closely matched the distribution of these drugs over the adult market, and not the drug utilization by children. Many drug studies in children have been performed since the introduction of the FDAMA. However, children infrequently use the drugs granted pediatric exclusivity. The priorities for pediatric drug research should be set by the need of the patients, not by market considerations. Springer-Verlag 2007-01-17 2007-08 /pmc/articles/PMC1914295/ /pubmed/17225950 http://dx.doi.org/10.1007/s00431-006-0381-z Text en © Springer-Verlag 2007
spellingShingle Original Paper
Boots, Isabelle
Sukhai, Rám N.
Klein, Richard H.
Holl, Robert A.
Wit, Jan M.
Cohen, Adam F.
Burggraaf, Jacobus
Stimulation programs for pediatric drug research – do children really benefit?
title Stimulation programs for pediatric drug research – do children really benefit?
title_full Stimulation programs for pediatric drug research – do children really benefit?
title_fullStr Stimulation programs for pediatric drug research – do children really benefit?
title_full_unstemmed Stimulation programs for pediatric drug research – do children really benefit?
title_short Stimulation programs for pediatric drug research – do children really benefit?
title_sort stimulation programs for pediatric drug research – do children really benefit?
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1914295/
https://www.ncbi.nlm.nih.gov/pubmed/17225950
http://dx.doi.org/10.1007/s00431-006-0381-z
work_keys_str_mv AT bootsisabelle stimulationprogramsforpediatricdrugresearchdochildrenreallybenefit
AT sukhairamn stimulationprogramsforpediatricdrugresearchdochildrenreallybenefit
AT kleinrichardh stimulationprogramsforpediatricdrugresearchdochildrenreallybenefit
AT hollroberta stimulationprogramsforpediatricdrugresearchdochildrenreallybenefit
AT witjanm stimulationprogramsforpediatricdrugresearchdochildrenreallybenefit
AT cohenadamf stimulationprogramsforpediatricdrugresearchdochildrenreallybenefit
AT burggraafjacobus stimulationprogramsforpediatricdrugresearchdochildrenreallybenefit