Pharmacogenomic information in drug labels: European Medicines Agency perspective.

Pharmacogenomics J

European Medicines Agency, Pharmacogenomics Working Party, London, UK.

Published: June 2015

AI Article Synopsis

Article 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.

Download full-text PDF

Source
http://dx.doi.org/10.1038/tpj.2014.86DOI Listing

Publication Analysis

Top Keywords

pharmacogenomic drug
12
drug labels
12
european medicines
8
medicines agency
8
drug treatment
8
labels
6
drug
5
pharmacogenomic
4
labels european
4
agency perspective
4

Similar Publications

Pharmacogenomics stands as a pivotal driver toward personalized medicine, aiming to optimize drug efficacy while minimizing adverse effects by uncovering the impact of genetic variations on inter-individual outcome variability. Despite its promise, the intricate landscape of drug metabolism introduces complexity, where the correlation between drug response and genes can be shaped by numerous nongenetic factors, often exhibiting heterogeneity across diverse subpopulations. This challenge is particularly pronounced in datasets such as the International Warfarin Pharmacogenetic Consortium (IWPC), which encompasses diverse patient information from multiple nations.

View Article and Find Full Text PDF

Introduction: Severe cutaneous adverse reactions (SCARs) are life-threatening and often linked to antiepileptic drugs (AEDs). Common types of SCARs include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Immune-mediated mechanisms involving human leukocyte antigen () alleles have been implicated in the pathogenesis of this reaction.

View Article and Find Full Text PDF

Monoclonal antibodies (mAbs) are critical components in the therapeutic landscape, but their dosing strategies often evolve post-approval as new data emerge. This review evaluates post-marketing label changes in dosing information for FDA-approved mAbs from January 2015 to September 2024, with a focus on both initial and extended indications. We systematically analyzed dosing modifications, categorizing them into six predefined groups: Dose increases or decreases, inclusion of new patient populations by body weight or age, shifts from body weight-based dosing to fixed regimens, and adjustments in infusion rates.

View Article and Find Full Text PDF

Efficacy and safety of rivaroxaban in preventing venous thromboembolism in postoperative patients with gynecological malignancies: protocol for a randomised controlled open-label trial (G-alfalfa trial).

BMJ Open

December 2024

Department of Pharmacy, Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetric & Gynecology and Pediatrics, Fujian Medical University, Fuzhou, China

Introduction: Compared with the guideline-recommended use of low-molecular weight heparin (LMWH) for 28 days to prevent venous thromboembolism (VTE) after cytoreductive surgery, oral rivaroxaban avoids the pain and inconvenience of daily injections and reduces medical expenses. The proposed randomised controlled trial (RCT) aims to compare the efficacy and safety of rivaroxaban and enoxaparin in preventing VTE in patients after surgery for gynaecological malignancies and to provide a reference for clinical medication prevention.

Methods And Analysis: This is a single-centre, randomised, controlled, open-label and assessor-blind clinical trial.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!