Asians should receive genetic test prior to initiating carbamazepine
An increased risk of serious skin reactions in Asians taking carbamazepine has prompted the FDA to include a recommendation for genetic testing prior to beginning treatment. According to the agency, the risk of life-threatening skin reactions in Caucasians is about one to six per 10,000 new users, but Asians? risk is some 10 times higher. Studies have found that there is a strong association between severe skin reactions and presence of inherited gene variant, HLA-B* 1502, found almost exclusively in people of Asian decent. Skin reaction warnings will now be included in the black box warning section of the prescribing information, along with a recommendation to healthcare providers to perform a genetic test in Asian patients prior to initiating therapy. Patients who do test positive for the variant should not receive the drug unless the benefit clearly outweighs the increased risk. Patients who have already taken carbamazepine for more than a few months without any skin reaction are unlikely to ever experience one, regardless of ancestry or genetic test results. See
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.