title: Pharmacogenomic information in drug labels: European Medicines Agency perspective.
abstract: Pharmacogenomics (PGx) has a growing impact on healthcare and constitutes one of the major pillars of personalised medicine. For the purpose of improved individualised drug treatment, there is an increasing effort to develop drugs suitable for specific subpopulations and to incorporate pharmacogenomic drug labels in existing and novel medicines. Here, we review the pharmacogenomic drug labels of all 517 medicinal products centrally approved in the European Union (EU) since the establishment of the European Medicines Agency in 1995. We identified all pharmacogenomic-related information mentioned in the product labels and classified it according to its main effect and function on drug treatment, that is, metabolism, transport and pharmacodynamics, and according to the place of the respective section of the Summary of Product Characteristics (SmPC). The labels are preferentially present in drugs having antineoplastic properties. We find that the number of drugs with pharmacogenomic labels in EU increases now steadily and that it will be an important task for the future to refine the legislation on how this information should be utilised for improvement of drug therapy.
authors.affiliation: European Medicines Agency, Pharmacogenomics Working Party, London, UK.
authors.forename: F
authors.initials: F
authors.lastname: Ehmann
authors.affiliation: European Medicines Agency, Pharmacogenomics Working Party, London, UK.
authors.forename: L
authors.initials: L
authors.lastname: Caneva
authors.affiliation: 1] Pharmacogenomics Working Party-European Medicines Agency (EMA), London, UK [2] Medicines and Healthcare products Regulatory Agency (MHRA), London, UK.
authors.forename: K
authors.initials: K
authors.lastname: Prasad
authors.affiliation: 1] Pharmacogenomics Working Party-European Medicines Agency (EMA), London, UK [2] Paracelsus Medical University, Salzburg, Austria.
authors.forename: M
authors.initials: M
authors.lastname: Paulmichl
authors.affiliation: 1] Pharmacogenomics Working Party-European Medicines Agency (EMA), London, UK [2] Medicines Evaluation Board, Utrecht, The Netherlands [3] Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.
authors.forename: M
authors.initials: M
authors.lastname: Maliepaard
authors.affiliation: 1] Pharmacogenomics Working Party-European Medicines Agency (EMA), London, UK [2] Extremadura University Hospital, Faculty of Medicine, Clinical Research Center, Badajoz, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Llerena
authors.affiliation: Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.
authors.forename: M
authors.initials: M
authors.lastname: Ingelman-Sundberg
authors.affiliation: European Medicines Agency, Pharmacogenomics Working Party, London, UK.
authors.forename: M
authors.initials: M
authors.lastname: Papaluca-Amati
mesh_terms: D004348:Drug Labeling / Q000379:methods*; D005060:Europe; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D010597:Pharmacogenetics / Q000379:methods*
chemical_list: D004364:Pharmaceutical Preparations