Showing posts with label side effect. Show all posts
Showing posts with label side effect. Show all posts

Sunday, February 10, 2008

Carbamazepine (Tegretol) and Asians warning


photo credit-PPDIGITAL
creative commons license


I missed this when it first came out, but came across it this weekend and thought I'd pass it along.

Asians (including those from south Asia) may have a genetic variation that makes them susceptible to very serious (sometimes fatal) skin reactions called Stevens-Johnson syndrome and toxic epidermal necrolysis. If you are of Asian descent and your doctor recommends carbamazepine, genetic testing should be performed before you take this.

Information for Healthcare Professionals
Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, and generics)

FDA ALERT [12/12/2007]: Dangerous or even fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine therapy, are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians. Genetic tests for HLA-B*1502 are already available. Patients with ancestry from areas in which HLA-B*1502 is present should be screened for the HLA-B*1502 allele before starting treatment with carbamazepine. If they test positive, carbamazepine should not be started unless the expected benefit clearly outweighs the increased risk of serious skin reactions. Patients who have been taking carbamazepine for more than a few months without developing skin reactions are at low risk of these events ever developing from carbamazepine. This is true for patients of any ethnicity or genotype, including patients positive for HLA-B*1502. This new safety information will be reflected in updated product labeling.

This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this when additional information or analyses become available.


The full FDA alert can be found here.