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Vol. 79, No. 1, 2013
Issue release date: February 2013
Section title: Opinion Paper
Horm Res Paediatr 2013;79:4–8
(DOI:10.1159/000346381)

Warning about Warnings: Weighing Risk and Benefit When Information Is in a State of Flux

Laventhal N.T. · Shuchman M. · Sandberg D.E.
aDepartment of Pediatrics and Communicable Diseases, and bCenter for Bioethics and Social Sciences in Medicine, University of Michigan, Ann Arbor, Mich., USA; cDepartment of Psychiatry, University of Toronto, Toronto, Ont., Canada

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Article / Publication Details

First-Page Preview
Abstract of Opinion Paper

Received: 12/10/2012 12:55:31 PM
Accepted: 12/10/2012
Published online: 1/22/2013

Number of Print Pages: 5
Number of Figures: 0
Number of Tables: 0

ISSN: 1663-2818 (Print)
eISSN: 1663-2826 (Online)

For additional information: http://www.karger.com/HRP

Abstract

In 2010, new data about the safety of recombinant human growth hormone (rhGH) resulted in warnings and subsequent pronouncements by the US Food and Drug Administration (FDA) and its European counterpart [the European Medicines Agency (EMA)] regarding its use in children and adolescents as an elective treatment for short stature. However, opinions about these new data are divergent: the FDA did not change the label of the drug and experts have argued for further research on the safety of rhGH. In this situation of an evolving scientific controversy, it is unclear how questions about benefit and risk are communicated to patients and their parents. Social biases and misperceptions about the deleterious effects of short stature and the benefits of added height influence decisions to prescribe rhGH and may affect discussions of the warnings by regulators. Fully supporting a model of shared decision-making involving children and adolescents requires sharing risk-benefit information, including evolving information from drug regulators, with patients and parents.


  

Author Contacts

Naomi Laventhal
8-621 C&W Mott Hospital
1540 E. Hospital Dr., SPC 4254
Ann Arbor, MI 48109-4254 (USA)
E-Mail naomilav@med.umich.edu

  

Article Information

Received: December 10, 2012
Accepted: December 10, 2012
Published online: January 23, 2013
Number of Print Pages : 5
Number of Figures : 0, Number of Tables : 0, Number of References : 43

  

Publication Details

Hormone Research in Paediatrics (From Developmental Endocrinology to Clinical Research)

Vol. 79, No. 1, Year 2013 (Cover Date: February 2013)

Journal Editor: Czernichow P. (Paris)
ISSN: 1663-2818 (Print), eISSN: 1663-2826 (Online)

For additional information: http://www.karger.com/HRP


Article / Publication Details

First-Page Preview
Abstract of Opinion Paper

Received: 12/10/2012 12:55:31 PM
Accepted: 12/10/2012
Published online: 1/22/2013

Number of Print Pages: 5
Number of Figures: 0
Number of Tables: 0

ISSN: 1663-2818 (Print)
eISSN: 1663-2826 (Online)

For additional information: http://www.karger.com/HRP


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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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