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

Laventhal N.T.a, b · Shuchman M.c · Sandberg D.E.a
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 Horm Res Paediatr 2013;79:4–8 (DOI:10.1159/000346381)

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.

 

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