Literature DB >> 24394201

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

D S L Toh1, L L Tan1, D C W Aw2, S M Pang3, S H Lim4, T Thirumoorthy3, H Y Lee3, Y K Tay5, S K Tan6, A Vasudevan7, A Lateef8, Y Y Chong9, Y C Chan10, C Loke1, C L Chan1, E S C Koay11, E C Ren12, E J D Lee13, C Sung14.   

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.

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Year:  2014        PMID: 24394201     DOI: 10.1038/tpj.2013.46

Source DB:  PubMed          Journal:  Pharmacogenomics J        ISSN: 1470-269X            Impact factor:   3.550


  14 in total

Review 1.  Global implementation of genomic medicine: We are not alone.

Authors:  Teri A Manolio; Marc Abramowicz; Fahd Al-Mulla; Warwick Anderson; Rudi Balling; Adam C Berger; Steven Bleyl; Aravinda Chakravarti; Wasun Chantratita; Rex L Chisholm; Vajira H W Dissanayake; Michael Dunn; Victor J Dzau; Bok-Ghee Han; Tim Hubbard; Anne Kolbe; Bruce Korf; Michiaki Kubo; Paul Lasko; Erkki Leego; Surakameth Mahasirimongkol; Partha P Majumdar; Gert Matthijs; Howard L McLeod; Andres Metspalu; Pierre Meulien; Satoru Miyano; Yaakov Naparstek; P Pearl O'Rourke; George P Patrinos; Heidi L Rehm; Mary V Relling; Gad Rennert; Laura Lyman Rodriguez; Dan M Roden; Alan R Shuldiner; Sukdeb Sinha; Patrick Tan; Mats Ulfendahl; Robyn Ward; Marc S Williams; John E L Wong; Eric D Green; Geoffrey S Ginsburg
Journal:  Sci Transl Med       Date:  2015-06-03       Impact factor: 17.956

Review 2.  Pharmacogenomics in the clinic.

Authors:  Mary V Relling; William E Evans
Journal:  Nature       Date:  2015-10-15       Impact factor: 49.962

Review 3.  Applications of pharmacogenomics in regulatory science: a product life cycle review.

Authors:  W C Tan-Koi; P C Leow; Y Y Teo
Journal:  Pharmacogenomics J       Date:  2017-12-05       Impact factor: 3.550

4.  Ethnicity-Specific Drug Safety Data in European Medicines Agency Registration Dossiers, European Public Assessment Reports, and European and Singapore Drug Labels: Lost in Translation?

Authors:  Marc Maliepaard; Anne C Taams; Cynthia Sung; Jalene Poh; Yang Yu
Journal:  Pharmaceut Med       Date:  2019-10

5.  PharmGKB summary: very important pharmacogene information for human leukocyte antigen B.

Authors:  Julia M Barbarino; Deanna L Kroetz; Teri E Klein; Russ B Altman
Journal:  Pharmacogenet Genomics       Date:  2015-04       Impact factor: 2.089

6.  Increased risk of strontium ranelate-related SJS/TEN is associated with HLA.

Authors:  H Y Lee; M X Shen; Y L Lim; Y K Tay; M M F Chan; S M Pang; Z W Xiao; S B Ang; E C Ren
Journal:  Osteoporos Int       Date:  2016-03-22       Impact factor: 4.507

Review 7.  SJS/TEN 2017: Building Multidisciplinary Networks to Drive Science and Translation.

Authors:  Katie D White; Riichiro Abe; Michael Ardern-Jones; Thomas Beachkofsky; Charles Bouchard; Bruce Carleton; James Chodosh; Ricardo Cibotti; Robert Davis; Joshua C Denny; Roni P Dodiuk-Gad; Elizabeth N Ergen; Jennifer L Goldman; James H Holmes; Shuen-Iu Hung; Mario E Lacouture; Rannakoe J Lehloenya; Simon Mallal; Teri A Manolio; Robert G Micheletti; Caroline M Mitchell; Maja Mockenhaupt; David A Ostrov; Rebecca Pavlos; Munir Pirmohamed; Elena Pope; Alec Redwood; Misha Rosenbach; Michael D Rosenblum; Jean-Claude Roujeau; Arturo P Saavedra; Hajirah N Saeed; Jeffery P Struewing; Hirohiko Sueki; Chonlaphat Sukasem; Cynthia Sung; Jason A Trubiano; Jessica Weintraub; Lisa M Wheatley; Kristina B Williams; Brandon Worley; Wen-Hung Chung; Neil H Shear; Elizabeth J Phillips
Journal:  J Allergy Clin Immunol Pract       Date:  2018 Jan - Feb

8.  Prevalence and characteristics of adverse drug reactions at admission to hospital: a prospective observational study.

Authors:  Sze Ling Chan; Xiaohui Ang; Levana L Sani; Hong Yen Ng; Michael D Winther; Jian Jun Liu; Liam R Brunham; Alexandre Chan
Journal:  Br J Clin Pharmacol       Date:  2016-09-19       Impact factor: 4.335

Review 9.  Applications of Immunopharmacogenomics: Predicting, Preventing, and Understanding Immune-Mediated Adverse Drug Reactions.

Authors:  Jason H Karnes; Matthew A Miller; Katie D White; Katherine C Konvinse; Rebecca K Pavlos; Alec J Redwood; Jonathan G Peter; Rannakoe Lehloenya; Simon A Mallal; Elizabeth J Phillips
Journal:  Annu Rev Pharmacol Toxicol       Date:  2018-08-22       Impact factor: 13.820

Review 10.  Genetic Determinants in HLA and Cytochrome P450 Genes in the Risk of Aromatic Antiepileptic-Induced Severe Cutaneous Adverse Reactions.

Authors:  Ali Fadhel Ahmed; Chonlaphat Sukasem; Majeed Arsheed Sabbah; Nur Fadhlina Musa; Dzul Azri Mohamed Noor; Nur Aizati Athirah Daud
Journal:  J Pers Med       Date:  2021-05-07
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