Citation

Vitiello B, Riddle MA, Greenhill LL, March JS, Levine J, Schachar RJ, Abikoff HB, Zito JM, McCracken JT, Walkup JT, Findling RL, Robinson J, Cooper TB, Davies M, Varipatis E, Labellarte MJ, Scahill L, Capasso L. J. Am. Acad. Child Adolesc. Psychiatry 2003; 42(6): 634-641.

Affiliation

Division of Services and Intervention Research, NIMH, Bethesda, MD 20982-9633, USA. bvitiell@nih.gov

Copyright

(Copyright © 2003, American Academy of Child Adolescent Psychiatry, Publisher Lippincott Williams and Wilkins)

DOI

10.1097/01.CHI.0000046840.90931.36

PMID

12921470

Abstract

OBJECTIVE: To identify approaches to improving methods for assessing tolerability and safety of psychotropic medications in children and adolescents. METHOD: Strengths and limitations of current methodology were reviewed and possible alternatives examined. RESULTS: Research on the validity of safety evaluation has been extremely limited. No evidence-based "gold standard" exists. Clinical trials remain the best design to establish causality, but sample size limitations prevent the detection of infrequent, though serious, adverse events. Other designs, such as cohort and case-control studies, and approaches, such as mining of large databases, must be considered. CONCLUSION: The current lack of methodological standardization across studies prevents generalizations and meta-analyses. Because the issues relevant to drug safety are diverse, a variety of methodological approaches and instruments are needed. It is, however, possible to adopt standard basic definitions of adverse events, degree of severity, ascertainment methods, and recording procedures, as a common "core," to which more specific assessment instruments can be added. Systematic empirical testing and validation of safety methodology is needed.

Language: en