Responding to the clopidogrel warning by the US food and drug administration: real life is complicated.

摘要

A sine qua non for drug approval by the US Food and Drug Administration (FDA) is demonstrated efficacy in populations of patients. However, it is virtually axiomatic that individuals vary in their responses to drugs. Work over decades has built a knowledge base that describes the role of genetic variation as a modulator of both drug efficacy and rare adverse drug effects. This increasing understanding of the role of genetics in variable drug responses led the FDA in 2007 to begin to incorporate pharmacogenetic information in drug labels.