Adverse Event Reporting News - Tegretol USP, chewable tablets, and oral suspension
Tegretol-XR (carbamazepine extendedrelease tablets)
BOXED WARNING
Serious Dermatologic Reactions and HLA-B*1502 Allele
Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), have been reported during treatment with Tegretol. These reactions are estimated to occur in 1 to 6 per 10,000 new users in countries with mainly caucasian populations, but the risk in some Asian countries is estimated to be about 10 times higher. Studies in patients of Chinese ancestry have found a strong association between the risk of developing SJS/TEN and the presence of HLA-B*1502, an inherited allelic variant of the HLA-B gene. HLA-B*1502 is found almost exclusively in patients with ancestry across broad areas of Asia. 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 (see WARNINGS and PRECAUTIONS, Laboratory Tests).
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WARNINGS
Serious Dermatologic Reactions
SJS/TEN and HLA-B*1502 Allele
Aplastic Anemia and Agranulocytosis
Patients with a history of adverse hematologic reaction to any drug may be particularly at risk of bone marrow depression.
PRECAUTIONS
Laboratory Tests
For genetically at-risk patients [see WARNINGS], high-resolution ‘HLA-B*1502 typing’ is recommended. The test is positive if either one or two HLA-B*1502 alleles are detected and negative if no HLA-B*1502 alleles are detected.
ADVERSE REACTIONS
Initial Section
The most severe adverse reactions have been observed in the hemopoietic system and skin (see BOXED WARNING), the liver and the cardiovascular system.
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COPYRIGHT 2008 Gale, Cengage Learning
