Carbamazepine, HLA-B*1502 and risk of Stevens-Johnson syndrome and toxic epidermal necrolysis: US FDA recommendations

Pharmacogenomics. 2008 Oct;9(10):1543-6. doi: 10.2217/14622416.9.10.1543.


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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Alleles
  • Asians / genetics
  • Carbamazepine / adverse effects*
  • Forecasting
  • Gene Frequency
  • HLA-B Antigens / genetics*
  • Health Planning Guidelines
  • Humans
  • Risk Factors
  • Stevens-Johnson Syndrome / chemically induced
  • Stevens-Johnson Syndrome / ethnology*
  • Stevens-Johnson Syndrome / genetics*
  • Stevens-Johnson Syndrome / immunology
  • United States
  • United States Food and Drug Administration*


  • HLA-B Antigens
  • Carbamazepine