Adverse Event Reporting News - Tegretol carries risk of serious skin conditions in Asian patients
Novartis Pharmaceuticals Canada, following discussion with Health Canada, has revised its Product Monograph for Tegretol (carbamazepine) to include in the WARNINGS section information about the risks of Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), particularly in patients of Asian descent.
Both conditions involve serious and sometimes fatal dermatologic reactions. The risk of SJS and TEN exists in all patients, but these reactions are generally very rare. However, in some Asian countries the risk is estimated to be approximately 10 times higher than in Western countries.
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In studies that included small samples of patients of Han Chinese ancestry a strong association was found between the risk of developing SJS/TEN and the presence of HLA-B1502, an inherited allelic variant of the HLA-B gene. The prevalence of this allele is negligible in Western Caucasian populations but is approximately 5-10% in Han Chinese, and ranges from
