FDA safety alert on carbamazepine

The FDA has issued a safety alert warning that the anticonvulsant carbamazepine significantly increases the riskof dangerous or fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis) in certain patientpopulations. These patients carry the human leukocyte antigen (HLA) allele, HLA-B*1502. This allele is almostexclusively found in patients with ancestry across broad areas of Asia, including South Asian Indians.

The FDA warned that carbamazepine therapy is not to be started in those patients carrying theHLA-B*1502 allele unless the expected benefit clearly outweighs the risk of skin reactions. Patients presentlytaking carbamazepine for more than a few months without developing skin reactions are at low risk ofcarbamazepine-induced skin reactions.

This new safety information and guidelines for testing for the HLAB*1502 allele in at-risk populationswill be added to the existing boxed warning and the product labeling for carbamazepine products including Carbatrol,Equetro, Tegretol, and generic carbamazepine. Carbamazepine is indicated for the treatment of epilepsy, mania/bipolardisorder, and neuropathic pain.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm150841.htm.