Adding pharmacogenetics information to drug labels: lessons learned.

Published

Journal Article (Review)

The US Food and Drug Administration approved a revised package insert for two cancer drugs to include information about the increased risk of severe adverse events owing to enzyme deficiencies caused by genetic variants. The label revisions stopped short of recommending or requiring pharmacogenetic testing prior to or following an adverse event. Despite (or because of) the lack of specific recommendations, we believe the actions taken by US Food and Drug Administration will have implications for pharmacogenetics research, clinical integration, and other policy considerations. We review the reasons behind the cautious label changes and discuss some of the lessons that can be learned from these experiences.

Full Text

Duke Authors

Cited Authors

  • Haga, SB; Thummel, KE; Burke, W

Published Date

  • December 2006

Published In

Volume / Issue

  • 16 / 12

Start / End Page

  • 847 - 854

PubMed ID

  • 17108808

Pubmed Central ID

  • 17108808

International Standard Serial Number (ISSN)

  • 1744-6872

Digital Object Identifier (DOI)

  • 10.1097/01.fpc.0000236322.88433.ac

Language

  • eng

Conference Location

  • United States