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Chunk #5 — Current Status of Drug Labeling and Pharmacogenomic Testing Guidelines

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Pharmacogenomic testing for neuropsychiatric drugs: current status of drug labeling, guidelines for using genetic information, and test options.
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Currently, there are 110 medications with pharmacogenomic biomarker information listed in the product labeling.2 Examples of neuropsychiatric medications with this information are listed in Table 1. Of the 32 neuropsychiatric medications listed, 27 (84%) have CYP2D6 metabolizer status listed as an important biomarker, 3 (9%) identify CYP2C19 metabolizer status as an important biomarker, and 3 (9%) pertain to other genetic markers (e.g., major histocompatibility complex human leukocyte antigen (HLA) allele HLA-B*1502 for carbamazepine and phenytoin, carbamoyl phosphate synthetase 1 [CPS1] and ornithine carbamoyltransferase [OTC] for valproic acid). Of the 32 neuropsychiatric medications listed, 10 have information related to dosing, precautions, or warnings (Table 1). Dosage changes for known poor metabolizers (PMs) for CYP2D6 or CYP2C19 are outlined for aripiprazole, atomoxetine, citalopram, clobazam, iloperidone, pimozide, and tetrabenazine. At the time of this review, carbamazepine had genetic information listed in the black-box warning section of the label, which was limited to the patients of Asian ancestry.