Carbamazepine

Pharmacogenomic Information in the Context of the FDA-Approved Drug Label*

The FDA recommends, but does not require, genetic testing of patients from at-risk populations prior to initiating treatment with Tegretol.

Excerpt from the carbamazepine drug label:

"Patients with ancestry in genetically at-risk populations should be screened for the presence of HLA-B*1502 prior to initiating treatment with Tegretol. Patients testing positive for the allele should not be treated with Tegretol unless the benefit clearly outweighs the risk . . ."

Studies have shown that, in patients of Chinese ancestry, there is a strong association between presence of one or two copies of the HLA-B*1502 allele and the risk of developing SJS/TEN (Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis). The HLA-B*1502 allele has been reported present in greater than 15% of the population in Hong Kong, Thailand, Malaysia, and parts of the Philippines, with lower prevalence in other parts of Asia. Not all Asian patients carrying HLA-B*1502 develop SJS/TEN, and, infrequently, HLA-B*1502-negative patients of any ethnicity do experience these reactions.

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the Carbamazepine drug label PDF.

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