title: Adding pharmacogenetics information to drug labels: lessons learned.
abstract: 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.
authors.affiliation: Institute for Genome Sciences & Policy, Duke University, Durham, North Carolina 27708, USA. susanne.haga@duke.edu
authors.forename: Susanne B
authors.initials: SB
authors.lastname: Haga
authors.forename: Kenneth E
authors.initials: KE
authors.lastname: Thummel
authors.forename: Wylie
authors.initials: W
authors.lastname: Burke
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000493:pharmacokinetics; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives / Q000493:pharmacokinetics; D004348:Drug Labeling; D014644:Genetic Variation; D014453:Glucuronosyltransferase / Q000235:genetics / Q000378:metabolism; D006801:Humans; D000077146:Irinotecan; D015122:Mercaptopurine / Q000009:adverse effects / Q000493:pharmacokinetics; D008780:Methyltransferases / Q000235:genetics / Q000378:metabolism; D010597:Pharmacogenetics; D014481:United States; D014486:United States Food and Drug Administration; D000099148:UGT1A1 Enzyme
chemical_list: D000970:Antineoplastic Agents; D002166:Camptothecin; D014453:Glucuronosyltransferase; D000077146:Irinotecan; D015122:Mercaptopurine; D008780:Methyltransferases; D000099148:UGT1A1 Enzyme; C022745:thiopurine methyltransferase