FDA: Carbamazepine Risks in Asians Reflected in Label
People of Asian descent have higher risk of developing serious skin reactions with carbamazepine
WEDNESDAY, Dec. 12 (HealthDay News) -- The U.S. Food and Drug Administration announced Wednesday that manufacturers of drugs containing carbamazepine have agreed to add a recommendation to the drugs' labeling that patients of Asian descent undergo blood testing prior to initiating therapy, to identify individuals at increased risk of developing serious skin complications. Carbamazepine is used in the treatment of epilepsy, bipolar disorder and neuropathic pain, and is sold under the trade names Carbatrol, Equetro and Tegretol.
Serious skin reactions including toxic epidermal necrolysis and Stevens-Johnson syndrome are rare but known complications of carbamazepine use, but the risk of these reactions may be elevated 10-fold in Asians over the general population. Thus, the FDA recommends that people with Asian ancestry undergo a blood test for the HLA-B* 1502 gene, found almost exclusively in people of Asian descent, which is associated with an increased risk of serious skin reactions.
Patients who have been taking carbamazepine for several months without any skin problems are unlikely to ever develop these serious skin reactions, regardless of ancestry or HLA-B* 1502 status, according to the FDA.
"When being considered for treatment with carbamazepine, genetically high-risk patients can be given a test that will help their health care providers make personalized drug treatment decisions and help avoid potentially serious skin reactions," said Janet Woodcock, M.D., FDA's acting director of the Center for Drug Evaluation and Research.