ABSTRACT
Two recent examples are the FDA re-labelings of warfarin and clopidogrel (Plavix)—the number two drug in the world. On January 22, 2010, FDA relabeled warfarin by stating: “e patient’s CYP2C9 and VKORC1 genotype information, when available, can assist in selection of the starting dose.” [4], and on March 12, 2010, FDA issued the boxed warning for clopidogrel “—alerting patients and health care professionals that the drug can be less eˆective in people who cannot metabolize the drug to convert it to its active form.—by the liver enzyme CYP 2C19-2 percent to 14 percent of the U.S. population are poor metabolizers. Tests are available to assess CYP2C19 genotype” [5]. e re-labeling of these antiplatelet drugs serve to demonstrate an eˆective quality assurance/regulatory process to ensure patient safety by using adjunct molecular diagnostics such as PGx. ese developments would impact the practice of forensic pathology and toxicology as well. For patients and decedents with history of intake of these two antiplatelet drugs and with bleeding complications, genotyping CYP2C9 and CYP2C19 would serve as useful interpretative adjuncts for therapy and forensic pathology/toxicology.
