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Dangerous Skin Reactions from Carbamazepine

Posted on April 29, 2008

FDA is alerting healthcare professionals about dangerous and possibly fatal skin reactions to the drug carbamazepine in certain patient populations. The reactions have included Stevens Johnson syndrome and toxic epidermal necrolysis.

Carbamazepine is an anticonvulsant used to treat epilepsy, as well as mania/bipolar disorder and neuropathic pain. This drug is sold under the trade names Carbatrol, Equetro and Tegretol, and also as a generic.

These skin reactions are significantly more common in patients with a particular human leukocyte antigen allele called HLA-B*1502. This allele occurs almost exclusively in people with Asian ancestry, including South Asian Indians. Patients with this ancestry should be screened for the HLA-B*1502 allele before starting treatment with carbamazepine, using available genetic tests.

If test results are positive, the drug should not be started unless the expected benefit clearly outweighs the risk of serious skin reactions.

Patients who test positive for HLA-B*1502 may also be at increased risk from other antiepileptic drugs that have caused serious skin reactions. So clinicians should consider avoiding these drugs when other treatments are equally acceptable.

Patients who test negative for HLA-B*1502 have a low risk of developing serious skin reactions from carbamazepine, but these reactions can still occur, although rarely. So healthcare professionals should watch for symptoms in any patient taking this drug.

But note that over 90 percent of all serious skin reactions do occur within the first few months of treatment. This means that patients who have been on the drug for longer periods of time without developing skin reactions have a low risk of this kind of reaction in the future. And that includes even those who test positive for HLA-B*1502.

Additional Information:

FDA MedWatch Safety Alert. Carbamazepine (marketed as Carbatrol, Equetro, Tegretol and generics). December 12, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#carbamazepine

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