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The Use of Genetics in Guiding Therapy

The FDA and PGx-Related Drug Label Updates

Slide 12

June 2012

The second PGx application that I would like to discuss is warfarin pharmacogenetics, which has 2 FDA-issued label warnings. The first was issued in August 2007, and was in reference to warfarin sensitivity in CYP2C9 poor metabolizers. The second warfarin label update was issued in January, 2010, and this label included the effect of a second gene, VKORC1, as well as a table with PGx guided dosing ranges for the drug.

FDA & PGx-Related Drug Label Updates


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