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

作者：Tan Koi W C; Lim Evelyn S H; Teo Y Y^*

来源：The Pharmacogenomics Journal, 2017, 17(2): 121-127.

DOI：10.1038/tpj.2016.5

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

• 出版日期2017-4