FDA Recommends Genetic Test for Certain Patients Considering Carbamazepine

Drugs containing carbamazepine will now include on their labeling a recommendation that patients with Asian ancestry get a genetic test prior to treatment.

Studies have found a strong association between certain serious skin reactions and a variant of a gene found almost exclusively in people with Asian ancestry, according to the FDA. The labeling for these drugs — used for treating epilepsy, bipolar disorder and neuropathic pain — already includes a warning of rare but severe skin reactions, including Stevens-Johnson syndrome.

Prospective patients who test positive for this gene should not begin treatment with the drug unless the benefit clearly outweighs the increased risk of these serious skin reactions, the agency said. But patients who have taken carbamazepine for more than a few months and haven’t experienced any skin reactions are unlikely to experience these side effects.

More information is available at www.fda.gov/cder/drug/InfoSheets/HCP/carbamazepineHCP.htm.