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Chunk #26 — Current Status of Drug Labeling and Pharmacogenomic Testing Guidelines — Labeling for Other Neuropsychiatric Drugs

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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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Several other neuropsychiatric drugs also include pharmacogenomic biomarker information in the FDA product labeling. This information is relevant to the warning, clinical pharmacology, drug interactions, and dosage and administration sections of the label. As highlighted in Table 1, the specificity and usefulness of pharmacogenomic language found in the product labeling is highly variable. The most refined examples include recommendations about dosing in patients of a specific metabolizer category if genetic information is known. Examples include atomoxetine, aripiprazole long-acting injection, clobazam, and iloperidone. The product labeling for many other medications may include information about the impact of CYP2C19 or CYP2D6 metabolizer status on the pharmacokinetic parameters of a drug or potential importance for drug interactions. No labeling or guidelines currently mandate that pharmacogenomic testing be performed; rather, they provide varying levels of recommendations for what implications that information may have if it is available.