30. Cognitive Development Considerations for Long-term Safety Exposures in Children

  1. Andrew E. Mulberg MD, FAAP, CPI4,
  2. Dianne Murphy MD, FAAP5,
  3. Julia Dunne MD6 and
  4. Lisa L. Mathis MD7
  1. Mary Pipan1,
  2. Paul P. Wang2 and
  3. Rebecca Thompson Penna3

Published Online: 31 JUL 2013

DOI: 10.1002/9781118312087.ch30

Pediatric Drug Development: Concepts and Applications

Pediatric Drug Development: Concepts and Applications

How to Cite

Pipan, M., Wang, P. P. and Thompson Penna, R. (2013) Cognitive Development Considerations for Long-term Safety Exposures in Children, in Pediatric Drug Development: Concepts and Applications (eds A. E. Mulberg, D. Murphy, J. Dunne and L. L. Mathis), John Wiley & Sons Ltd., Chichester, UK. doi: 10.1002/9781118312087.ch30

Editor Information

  1. 4

    Division Deputy Director, Gastroenterology and Inborn Error Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

  2. 5

    Director, Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD

  3. 6

    Group Manager, Special Populations Unit, Division of Vigilance and Risk Management of Medicines (VRRM), Medicines and Healthcare Products Regulatory Agency, London, UK

  4. 7

    Executive Director for Global Regulatory Affairs and Safety (GRAAS), Amgen Incorporated Thousand Oaks, CA

Author Information

  1. 1

    The Children's Hospital of Philadelphia, Division of Developmental Medicine and Metabolism, Philadelphia, PA, USA

  2. 2

    Seaside Therapeutics, Inc., Cambridge, MA, USA

  3. 3

    Center for Autism Research, Children's Hospital of Philadelphia, Philadelphia, PA, USA

Publication History

  1. Published Online: 31 JUL 2013
  2. Published Print: 12 AUG 2013

ISBN Information

Print ISBN: 9781118312155

Online ISBN: 9781118312087

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Keywords:

  • children;
  • cognition assessment change;
  • cognitive development;
  • long-term safety exposures;
  • psychotropic medications

Summary

This chapter summarizes the issues involved in determining the effects of medication on cognition and development in children. First, it discusses the mechanisms by which medication can affect cognition. Then, it considers what is known about the cognitive effects of the various classes of psychotropic medications used in pediatrics, considering adult studies if there are no data in children. Lastly, the chapter explores the complications involved in the assessment of change of cognition in children, and briefly describes the tools that have been used to assess change.