| Pediatric drug surveillance and the Food and Drug Administration's adverse event reporting system: an overview of reports, 2003-2007. | |
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MedLine Citation:
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PMID: 19009550 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: Our objective was to examine the numbers and characteristics of US pediatric adverse events (AEs) reported to the Food and Drug Administration (FDA)'s adverse event reporting system (AERS) for 5 years following implementation of the Best Pharmaceuticals for Children Act (BPCA) in 2002. METHODS: We analyzed reports in AERS received by FDA from January 1, 2003 to January 1, 2008 for overall numbers, age, gender, and seriousness of outcome in children and adults. Pediatric and adult age groups (<2, 2-10, 11-17, 18-50, and >50 years of age) were further evaluated for most frequently reported suspect drug classes and AEs. RESULTS: Seventy-two percent of 815 267 crude count reports had specified age information. Six percent of the total reports with age information reported age <18 years. Numbers of AEs being reported for children have remained steady, while those for adults have increased. The proportion of serious AEs reported was similar for pediatrics as compared to adults. Frequently reported suspect drug classes noted in pediatric age groups that were not observed in adults included anticonvulsants, attention deficit hyperactivity disorder (ADHD), anti-acne, and respiratory medications. CONCLUSIONS: This overview highlights the need for strengthening the passive drug surveillance system from a pediatric perspective, as well as investing in more active surveillance systems. Drug safety initiatives to better capture risk information in order to balance the risk/benefit of drug use in children. |
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Authors:
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Rosemary Johann-Liang; Jo Wyeth; Min Chen; Judith U Cope |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Pharmacoepidemiology and drug safety Volume: 18 ISSN: 1099-1557 ISO Abbreviation: Pharmacoepidemiol Drug Saf Publication Date: 2009 Jan |
Date Detail:
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Created Date: 2009-01-05 Completed Date: 2009-02-02 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9208369 Medline TA: Pharmacoepidemiol Drug Saf Country: England |
Other Details:
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Languages: eng Pagination: 24-7 Citation Subset: IM |
Affiliation:
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Health Resources and Services Administration, Department of Health and Human Services, Rockville, MD 20857, USA. Rjohann-liang@hrsa.gov |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Acne Vulgaris
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drug therapy Adolescent Adult Adverse Drug Reaction Reporting Systems / statistics & numerical data* Age Factors Anticonvulsants / adverse effects Attention Deficit Disorder with Hyperactivity / drug therapy Child Child, Preschool Dermatologic Agents / adverse effects Humans Infant Middle Aged Pharmaceutical Preparations / adverse effects* Respiratory Tract Diseases / drug therapy Severity of Illness Index United States United States Food and Drug Administration* Young Adult |
| Chemical | |
Reg. No./Substance:
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0/Anticonvulsants; 0/Dermatologic Agents; 0/Pharmaceutical Preparations |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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