Ancestry-based pharmacogenomics, adverse reactions and carbamazepine: Is the FDA warning correct?

Pharmacogenomics Journal

Volumn 14, Issue 5, 2014, Pages 473-480

  Payne, P W ^a,b  

^a GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES   (United States)

^b GEORGE WASHINGTON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARBAMAZEPINE; HLA B ANTIGEN; ANTICONVULSIVE AGENT; HLA B15 ANTIGEN; HLA-B*15:02 ANTIGEN;

ADVERSE DRUG REACTION; ALLELE; ANCESTRY GROUP; ARTICLE; ASIA; DRUG INFORMATION; DRUG LABELING; EPILEPSY; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; HUMAN; INDIAN; MACULOPAPULAR RASH; PHARMACOGENOMICS; POPULATION BASED CASE CONTROL STUDY; PRIORITY JOURNAL; SKIN MANIFESTATION; SKIN TOXICITY; SOUTH ASIAN; STEVENS JOHNSON SYNDROME; SYSTEMATIC REVIEW; TOXIC EPIDERMAL NECROLYSIS; UNITED STATES; ASIAN CONTINENTAL ANCESTRY GROUP; GENETICS; LEGISLATION AND JURISPRUDENCE; PHARMACOGENETICS; REPRODUCIBILITY;

ALLELES; ANTICONVULSANTS; ASIAN CONTINENTAL ANCESTRY GROUP; CARBAMAZEPINE; HLA-B15 ANTIGEN; HUMANS; PHARMACOGENETICS; REPRODUCIBILITY OF RESULTS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84927177449     PISSN: 1470269X     EISSN: 14731150     Source Type: Journal    
DOI: 10.1038/tpj.2014.14     Document Type: Article

References (32)

1. US Food and Drug Administration, Information for Healthcare Professionals: Dangerous or Even Fatal Skin Reactions-Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, and generics). 2007, available at http://www.fda.gov/Drugs/ DrugSafety/PostmarketdrugsafetyinformationforPatientsandProviders/ ucm124718.htm. Accessed on 15 June 2012.
2. Payne Jr. PW. For Asians only? The perils of ancestry-based drug prescribing. J Law Med Ethics 2008; 36: 585-588.
3. Ganesan S, Hussain N. Should phenytoin and carbamazepine be avoided in Asian populations with the HLA-B1502 positive genetic variant? Arch Dis Child 2011; 96: 104-106.
4. Yip V, Marson A, Jorgensen A, Pirmohamed M, Alfirevic A. HLA genotype and carbamazepine-induced cutaneous adverse drug reactions: a systematic review. Clin Pharmacol Ther 2012; 92: 757-765.
5. Chung W, Hung S, Hong H, Hsih M, Yang L, Ho H, et al. Medical genetics: a marker for Stevens-Johnson syndrome. Nature 2004; 428: 486.
6. Hung S, Chung W, Jee S, Chen W, Chang Y, Lee W, et al. Genetic susceptibility to carbamazepine-induced cutaneous adverse drug reactions. Pharmacogenet Genomics 2006; 16: 297-306.
7. Lonjou C, Thomas L, Borot N, Ledger N, de Toma C, LeLouet H, et al. A marker for Stevens-Johnson syndrome: ethnicity matters. Pharmacogenomics J. 2006; 6: 265-268.
8. Man C, Kwan. P, Baum L, Yu E, Lau K, Cheng A, et al. Association between HLAB 1502 allele and antiepileptic drug-induced cutaneous reactions in Han Chinese. Epilepsia 2007; 48: 1015-1018.
9. Locharernkul C, Loplumlert J, Limotai C, Korkij W, Desudchit T, Tongkobpetch S, et al. Carbamazepine and phenytoin induced Stevens-Johnson syndrome is associated with HLA-B1502 allele in Thai population. Epilepsia 2008; 49: 2087-2091.
10. Tassaneeyakul W, Tiamkao S, Jantararoungtong T, Chen P, Lin S, Chen W, et al. Association between HLA-B1502 and carbamazepine-induced severe cutaneous adverse drug reactions in a Thai population. Epilepsia 2010; 51: 926-930.
11. Kulkantrakorn K, Tassaneeyakul W, Tiamkao S, Jantararoungtong T, Prabmechai N, Vannaprasaht S, et al. HLA-B1502 strongly predicts carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in Thai patients with neuropathic pain. Pain Pract 2012; 12: 202-208.
12. Mehta T, Prajapati L, Mittal B, Joshi C, Sheth J, Patel D, et al. Association of HLAB 1502 allele and carbamazepine-induced Stevens-Johnson syndrome among Indians. Indian J Dermatol Venereol Leprol 2009; 75: 579-582.
13. Chang C, Too C, Murad S, Hussein S. Association of HLA-B1502 allele with carbamazepine-induced toxic epidermal necrolysis and Stevens-Johnson syndrome in the multi-ethnic Malaysian population. Int J Dermatol 2011; 50: 221-224.
14. Wu X, Hu F, An D, Yan B, Jiang X, Kwan P, et al. Association between carbamazepine-induced cutaneous adverse drug reactions and the HLA-B1502 allele among patients in central China. Epilepsy Behav. 2010; 19: 405-408.
15. Zhang Y, Wang J, Zhao L, PengW, Shen G, Xue L, et al. Strong association between HLAB 1502 and carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in mainland Han Chinese patients. Eur J Clin Pharmacol 2011; 67: 885-887.
16. Wang Q, Zhou J, Zhou L, Chen Z, Fang Z, Chen S, et al. Association between HLAB 1502 allele and carbamazepine-induced severe cutaneous adverse reactions in Han people of southern China mainland. Seizure 2011; 20: 446-448.
17. Then S, Rani Z, Raymond A, Ratnaningrum S, Jamal R. Frequency of the HLA-B1502 allele contributing to carbamazepine-induced hypersensitivity reactions in a cohort of Malaysian epilepsy patients. Asian Pac J Allergy Immunol 2011; 29: 290-293.
18. Shi Y, Min F, Qin B, Zou X, Liu X, Gao M, et al. Association between HLA and Stevens-Johnson syndrome induced by carbamazepine in Southern Han Chinese: genetic markers besides B1502? Basic Clin Pharmacol Toxicol 2012; 111: 58-64.
19. Asia. Encyclopædia Britannica. Encyclopædia Britannica Online. Encyclopædia Britannica, 2012. Web. 26 Jun. 2012 http://www.britannica.com/EBchecked/topic/ 38479/Asia.
20. Central Intelligence Agency. CIA World Factbook, Welcome to the World Factbook, available at https://www.cia.gov/library/publications/the-world-factbook/ wfbExt/region-eur.html. Accessed on 15 June 2012.
21. Central Intelligence Agency. CIA World Factbook, East and Southeast Asia, available at https://www.cia.gov/library/publications/the-world-factbook/wfbExt/ region-eas.html. Accessed on 15 June 2012.
22. Central Intelligence Agency. CIA World Factbook, South Asia, available at https://www.cia.gov/library/publications/the-world-factbook/wfbExt/region-sas.html. Accessed on 15 June 2012.
23. Central Intelligence Agency. CIA World Factbook, Central Asia, available at https://www.cia.gov/library/publications/the-world-factbook/wfbExt/region-cas.html. Accessed on 15 June 2012.
24. Kaniwa N, Saito Y, Aihara M, Matsunaga K, Tohkin M, Kurose K, et al. HLA-B locus in Japanese patients with anti-epileptics and allopurinol-related Stevens-Johnson syndrome and toxic epidermal necrolysis. Pharmacogenomics 2008; 9: 1617-1622.
25. Ikeda H, Takahashi Y, Yamazaki E, Fujiwara T, Kaniwa N, Saito Y, et al. HLA class I markers in Japanese patients with carbamazepine induced cutaneous adverse reactions. Epilepsia 2010; 51: 297-300.
26. Kaniwa N, Saito Y, Aihara M, Matsunaga K, Tohkin M, Kurose K, et al. HLA-B1511 is a risk factor for carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis in Japanese patients. Epilepsia 2010; 51: 2461-2465.
27. Kashiwagi M, Aihara M, Takahashi Y, Muramatsu M, Ikezawa Z. HLA genotypes in carbamazepine induced severe cutaneous adverse drug response in Japanese patients. J Dermatol 2008; 35: 683-685.
28. Aihara M. Pharmacogenetics of cutaneous adverse drug reactions. J Dermatol 2011; 38: 246-254.
29. Kim S, Lee K, Song W, Kim S, Jee Y, Lee S, et al. Adverse Drug Reaction Research Group in Korea. Carbamazepine-induced severe cutaneous adverse reactions and HLA genotypes in Koreans. Epilepsy Res. 2011; 97: 190-197.
30. Alfirevic A, Jorgensen A, Williamson P, Chadwick D, Park B, Pirmohamed M. HLA-B locus in Caucasian patients with carbamazepine hypersensitivity. Pharmacogenomics 2006; 7: 813-818.
31. Tennis P, Stern R. Risk of serious cutaneous disorders after initiation of use of phenytoin, carbamazepine, or sodium valproate: a record linkage study. Neurology 1997; 49: 542-546.
32. Mockenhaupt M, Messenheimer J, Tennis P, Schlingmann J. Risk of Stevens-Johnson syndrome and toxic epidermal necrolysis in new users of antiepileptics. Neurology 2005; 64: 1134-1138.