lunes, 20 de enero de 2014

Building pharmacogenetics into a pharmaco... [Pharmacogenomics J. 2014] - PubMed - NCBI

Building pharmacogenetics into a pharmaco... [Pharmacogenomics J. 2014] - PubMed - NCBI

 2014 Jan 7. doi: 10.1038/tpj.2013.46. [Epub ahead of print]

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


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.The Pharmacogenomics Journal advance online publication, 7 January 2014; doi:10.1038/tpj.2013.46.

[PubMed - as supplied by publisher]

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