Healthy Skepticism Library item: 8269

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Publication type: Journal Article

Haga SB, Thummel KE, Burke W.
Adding pharmacogenetics information to drug labels: lessons learned.
Pharmacogenet Genomics 2006 Dec; 16:(12):847-54
http://meta.wkhealth.com/pt/pt-core/template-journal/lwwgateway/media/landingpage.htm?an=01213011-200612000-00001

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.

Keywords:
Publication Types: Research Support, N.I.H., Extramural Review MeSH Terms: 6-Mercaptopurine/adverse effects 6-Mercaptopurine/pharmacokinetics Antineoplastic Agents/adverse effects Antineoplastic Agents/pharmacokinetics Camptothecin/adverse effects Camptothecin/analogs & derivatives Camptothecin/pharmacokinetics Drug Labeling* Glucuronosyltransferase/genetics Glucuronosyltransferase/metabolism Humans Methyltransferases/genetics Methyltransferases/metabolism Pharmacogenetics* United States United States Food and Drug Administration Variation (Genetics) Substances: Antineoplastic Agents irinotecan 6-Mercaptopurine Camptothecin Methyltransferases thiopurine methyltransferase bilirubin uridine-diphosphoglucuronosyl transferase 1A1 Glucuronosyltransferase