Pharmacogenomics and pharmacologic class effect in drug safety management.

Abstract

The safety of FDA-approved drugs remains a significant concern for patients and medical practitioners. This paper argues that pharmacogenomics can complement pharmacologic class effects in drug-safety management, and their use can be implemented without excessive costs or other impracticalities. Section I of this paper introduces key data, concepts and terms; Section II discusses the phenomenon of pharmacologic class effect as well as the relationship between this phenomenon and the use of pharmacogenomics in both FDA regulation and medical practice; and Section III proposes a means by which simultaneous consideration of pharmacologic class effect and pharmacogenomics can improve the quality of selective risk management.