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Health regulatory communications of well-established safety-related pharmacogenomics associations in six developed countries: an evaluation of alignment

The Pharmacogenomics Journal volume 17, pages 121–127 (2017)Cite this article

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Abstract

Recommendations on genetic testing are typically conveyed by drug regulatory authorities through drug labels, which are legal requirements for market authorization of drugs. We conducted a cross-sectional study of drug labels focusing on three crucial aspects of regulatory pharmacogenomics communications: (i) intent; (ii) interpretation in the local context; and (iii) implications of the genetic information. Labels of drugs associated with well-established safety-related genetic markers for adverse drug reactions across six developed countries of United States, Canada, United Kingdom, Australia, New Zealand and Singapore were reviewed. We found differing medical advice for genotype-positive HLA-B*15:02, HLA-A*31:01, UGT1A1*28 and CYP2D6 ultra-rapid metabolisers in breastfeeding women. This raises questions on implications to clinical practice between these countries. Varying ways of presenting at-risk population and allele frequencies also raises question in incorporating such information in drug labels. An international guidance addressing these crucial aspects of regulatory pharmacogenomic communications in drug labels is long overdue.

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Acknowledgements

WCTK and YYT acknowledge support from the Saw Swee Hock School of Public Health, National University of Singapore. YYT additionally acknowledges support by the National Research Foundation, Prime Minister’s Office, Singapore under its Research Fellowship (NRF-RF-2010-05) and administered by the National University of Singapore.

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Authors and Affiliations

  1. Saw Swee Hock School of Public Health, National University of Singapore, Singapore

    W C Tan-Koi, Evelyn S H Lim & Y Y Teo

  2. Life Sciences Institute, National University of Singapore, Singapore

    Y Y Teo

  3. Department of Statistics and Applied Probability, National University of Singapore, Singapore

    Y Y Teo

  4. NUS Graduate School for Integrative Science and Engineering, National University of Singapore, Singapore

    Y Y Teo

  5. Genome Institute of Singapore, Agency for Science, Technology and Research, Singapore

    Y Y Teo

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  1. W C Tan-Koi
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Correspondence to Y Y Teo.

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Tan-Koi, W., Lim, E. & Teo, Y. Health regulatory communications of well-established safety-related pharmacogenomics associations in six developed countries: an evaluation of alignment. Pharmacogenomics J 17, 121–127 (2017). https://doi.org/10.1038/tpj.2016.5

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