Building pharmacogenetics into a pharmacovigilance program in Singapore: using serious skin rash as a pilot study View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2014-08

AUTHORS

D S L Toh, L L Tan, D C W Aw, S M Pang, S H Lim, T Thirumoorthy, H Y Lee, Y K Tay, S K Tan, A Vasudevan, A Lateef, Y Y Chong, Y C Chan, C Loke, C L Chan, E S C Koay, E C Ren, E J D Lee, C Sung

ABSTRACT

To study the possible genetic associations with adverse drug reactions (ADR), the Singapore Health Sciences Authority (HSA) has piloted a program to collect DNA and phenotype data of ADR cases as part of its pharmacovigilance program. Between 2009 and 2012, HSA screened 158 cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). To assess the association between HLA-B*1502 and carbamazepine (CBZ)-induced SJS/TEN, 13 cases and 26 drug-tolerant controls were analyzed. All 13 CBZ-SJS/TEN cases and 3/26 controls were HLA-B*1502 positive (odds ratio 181, 95% confidence interval: 8.7-3785, P=6.9 × 10(-8)). Discussions of the finding with the Ministry of Health and an expert panel led to the decision to make HLA-B*1502 testing the standard of care prior to first use of CBZ in Asians and to subsidize the genotyping test at public hospitals. This program illustrates the role of a regulatory authority in advancing the use of pharmacogenetics for drug safety. More... »

PAGES

316

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/tpj.2013.46

DOI

http://dx.doi.org/10.1038/tpj.2013.46

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1034531541

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/24394201


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