title: Dosing recommendations for pharmacogenetic interactions related to drug metabolism.
abstract: Pharmacogenomic studies have established the important contribution of drug-metabolizing enzyme genotype toward drug toxicity and treatment failure; however, clinical implementation of pharmacogenomics has been slow. The aim of this study was to systematically review the information on drug-metabolizing enzyme pharmacogenomics available in the US drug labeling, practice guidelines, and recommendations.
  
  
  
  Drug-metabolizing enzyme genotype and phenotype information was assessed in US FDA drug labeling, clinical practice guidelines, and independent technology assessors to evaluate the consistency in information sources for healthcare providers.
  
  
  
  Eighty four gene-drug pairs were identified as having drug-metabolizing enzyme genotype or phenotype information within the label. The manner in which pharmacogenomic information was presented was heterogeneous both within the label and between clinical practice recommendations.
  
  
  
  For proper implementation of pharmacogenomics in clinical practice, information sources for healthcare providers should relay consistent and clear information for the appropriate use of biomarkers.
authors.affiliation: aEpidemiology and Genomics Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville bOffice of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland cMaine Dartmouth Family Medicine Residency Program, Augusta, Maine, USA.
authors.forename: Kelly K
authors.initials: KK
authors.lastname: Filipski
authors.forename: Michael A
authors.initials: MA
authors.lastname: Pacanowski
authors.forename: Anuradha
authors.initials: A
authors.lastname: Ramamoorthy
authors.forename: William Gregory
authors.initials: WG
authors.lastname: Feero
authors.forename: Andrew N
authors.initials: AN
authors.lastname: Freedman
mesh_terms: D015415:Biomarkers; D003577:Cytochrome P-450 Enzyme System / Q000235:genetics*; D004305:Dose-Response Relationship, Drug; D016903:Drug Monitoring; D064420:Drug-Related Side Effects and Adverse Reactions; D005838:Genotype; D006801:Humans; D004364:Pharmaceutical Preparations / Q000378:metabolism*; D010597:Pharmacogenetics; D010641:Phenotype; D017410:Practice Guidelines as Topic
chemical_list: D015415:Biomarkers; D004364:Pharmaceutical Preparations; D003577:Cytochrome P-450 Enzyme System