Special Report
Carbamazepine, HLA-B*1502 and risk of Stevens–Johnson syndrome and toxic epidermal necrolysis: US FDA recommendations
Published Online:14 Oct 2008https://doi.org/10.2217/14622416.9.10.1543
Abstract
Recently, the USA FDA has made a labeling change to the drug information contained in carbamazepine. Owing to recent data implicating the HLA allele B*1502 as a marker for carbamazepine-induced Stevens–Johnson syndrome and toxic epidermal necrolysis in Han Chinese, the FDA recommends genotyping all Asians for the allele. This allele is seen in high frequency in many Asian populations other than Han Chinese, but there are few data on whether the allele is a marker for this severe outcome in anyone other than Han Chinese. In fact, the association has not been found in Caucasian patients. We review the data that prompted this recommendation, list data for other ethnic groups, both Asian and non-Asian, and briefly discuss the implication of this recommendation for clinical practice.
Keywords:
Papers of special note have been highlighted as of interest (•).
Bibliography
- 1 Tennis P, Stern RS: Risk of serious cutaneous disorders after initiation of use of phenytoin, carbamazepine, or sodium valproate: a record linkage study. Neurology49,542–546 (1997).
- 2 Rzany B, Correia O, Kelly JP, Naldi L, Auquier A, Stern R: Risk of Stevens–Johnson syndrome and toxic epidermal necrolysis during first weeks of antiepileptic therapy: a case–control study. Study Group of the International Case Control Study on Severe Cutaneous Adverse Reactions. Lancet353,2190–2194 (1999).
- 3 Sharma VK, Vatve M, Sawhney IM, Kumar B: Clinical spectrum of drug rashes due to antiepileptics. J. Assoc. Physicians India46,595–597 (1998).
- 4 Bastuji-Garin S, Rzany B, Stern RS, Shear NH, Naldi L, Roujeau JC: Clinical classification of cases of toxic epidermal necrolysis, Stevens–Johnson syndrome, and erythema multiforme. Arch. Dermatol.129,92–96 (1993).• Recognized criteria for classification of severe cutaneous reactions.
- 5 Wolf R, Wolf D, Davidovici B: In the pursuit of classifying severe cutaneous adverse reactions. Clin. Dermatol.25,348–349 (2007).
- 6 Garcia-Doval I, LeCleach L, Bocquet H et al.: Toxic epidermal necrolysis and Stevens–Johnson syndrome: does early withdrawal of causative drugs decrease the risk of death? Arch. Dermatol.136,323–327 (2000).
- 7 Khalili B, Bahna SL: Pathogenesis and recent therapeutic trends in Stevens–Johnson syndrome and toxic epidermal necrolysis. Ann. Allergy Asthma Immunol.97(3),272–280; quiz 281–283, 320 (2006).
- 8 Chung WH, Hung SI, Hong HS et al.: Medical genetics: a marker for Stevens–Johnson syndrome. Nature428,486 (2004).• First report of HLA-B*1502 being associated with Stevens–Johnson syndrome/toxic epidermal necrolysis.
- 9 Hung SI, Chung WH, Jee SH et al.: Genetic susceptibility to carbamazepine-induced cutaneous adverse drug reactions. Pharmacogenet. Genomics16,297–306 (2006).
- 10 Man C, Kwan P, Baum L, Yu E et al.: Association between HLA-B*1502 allele and antiepileptic drug-induced cutaneous reactions in Han Chinese. Epilepsia48,1015–1018 (2007).
- 11 Devi K, George S, Criton S, Suja V, Sridevi PK: Carbamazepine – the commonest cause of toxic epidermal necrolysis and Stevens–Johnson syndrome: a study of 7 years. Indian J. Dermatol. Venereol. Leprol.71,325–328 (2005).
- 12 Sharma VK, Sethuraman G, Kumar B: Cutaneous adverse drug reactions: clinical pattern and causative agents – a 6 year series from Chandigarh, India. J. Postgrad. Med.47,95–99 (2001).
- 13 Kamaliah MD, Zainal D, Mokhtar N, Nazmi N: Erythema multiforme, Stevens–Johnson syndrome and toxic epidermal necrolysis in northeastern Malaysia. Int. J. Dermatol.37,520–523 (1998).
- 14 Khoo AK, Foo CL: Toxic epidermal necrolysis in a burns centre: a 6-year review. Burns22,275–278 (1996).
- 15 Leenutaphong V, Sivayathorn A, Suthipinittharm P, Sunthonpalin P: Stevens–Johnson syndrome and toxic epidermal necrolysis in Thailand. Int. J. Dermatol.6,428–431 (1993).
- 16 Alfirevic A, Jorgensen AL, Williamson PR, Chadwick DW, Park BK, Pirmohamed M: HLA-B locus in Caucasian patients with carbamazepine hypersensitivity. Pharmacogenomics7,813–818 (2006).• Shows relative lack of correlation between Stevens–Johnson syndrome/toxic epidermal necrolysis in HLA-B*1502 in Caucasian patients.
- 17 Lonjou C, Thomas L, Borot N et al.: A marker for Stevens–Johnson syndrome – ethnicity matters. Pharmacogenomics J.6,265–268 (2006).
- 18 Beran RG: Cross-reactive skin eruption with both carbamazepine and oxcarbazepine. Epilepsia34,163–165 (1993).
- 19 Hung SI, Chung WH, Liou LB et al.: HLA-B*5801 allele as a genetic marker for severe cutaneous adverse reactions caused by allopurinol. Proc. Natl Acad. Sci. USA102,4134–4139 (2005).
- 20 Mallal S, Phillips E, Carosi G et al.: HLA-B*5701 screening for hypersensitivity to abacavir. N. Engl. J. Med.358,568–579 (2008).
- 101 US FDA: 2007 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements (2008) www.fda.gov/medwatch/safety/2007/safety07.htm#carbamazepine
- 102 Middleton D: Allele Frequencies in Worldwide Populations www.allelefrequencies.net
- 103 International Histocompatibility Working Group www.ihwg.org
