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4 - Overview: Adverse Drug Reactions

from I - Critical Concepts

Published online by Cambridge University Press:  05 June 2012

Russ B. Altman
Affiliation:
Stanford University, California
David Flockhart
Affiliation:
Indiana University
David B. Goldstein
Affiliation:
Duke University, North Carolina
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Summary

Adverse drug reactions occur during drug development and in clinical practice with approved medicines. They are responsible for the termination of approximately 20 percent of investigational drugs in the pharmaceutical pipeline. Approximately 1 percent of marketed drugs are withdrawn or restricted postmarketing because of safety-related issues. Adverse drug reactions affect millions of people every year, are responsible for a significant fraction of hospitalizations, and are a leading cause of death in developed countries. Thus, patients, the medical community, health care providers, regulatory agencies, and the pharmaceutical industry have a compelling interest to understand these adverse reactions and identify factors that influence them.

In this chapter we define adverse drug reactions and several related and commonly used terms; evaluate their impact on drug development, public health, and individual patient well-being; provide an overview of the contribution of known genetic variants to adverse drug reaction risk; and discuss efforts to identify genetic adverse drug reaction risk factors and incorporate them into development and clinical practice.

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Publisher: Cambridge University Press
Print publication year: 2012

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