The Use of Genetics in Guiding Therapy

The FDA and PGx-Related Drug Label Updates

June 2012

The next PGx-related application that I will be discussing is irinotecan toxicity due to UGT1A1 deficiency. The FDA label warning for this PGx application was issued in July of 2005.

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FDA & PGx-Related Drug Label Updates

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Jump to section:

• Introduction
• Pharmacogenomics
• PGx Biomarkers in Drug Labels
• FDA-Approved Drugs with PGx-Related Label Information
• FDA-Approved Drugs with PGx-Related Label Information
• The FDA and PGx-Related Drug Label Updates
• Clopidogrel (Plavix)
• CYP2C19 and Response to Clopidogrel
• CYP2C19 and Response to Clopidogrel (cont)
• CYP2C19 PGx Testing for Clopidogrel
• Mayo CYP2C19 Test
• The FDA and PGx-Related Drug Label Updates
• Warfarin
• Warfarin PGx
• Allele Frequencies
• Medco-Mayo Warfarin Effectiveness Study
• Mayo Test for Warfarin Sensitivity
• FDA-Approved Drugs with PGx-Related Label Information
• Most Psychotropic Medications Are Metabolized by CYPs
• CYP450 Testing — Psychotherapeutics
• CYP2D6
• Mayo Test for CYP2D6
• Mayo Tests for CYP2D6
• Additional Mayo Tests for Psychiatric Applications
• The FDA and PGx-Related Drug Label Updates
• UGT1A1
• Irinotecan Metabolism
• UGT1A1 Genetic Variants
• Mayo Tests for UGT1A1
• The FDA and PGx-Related Drug Label Updates
• Human Leukocyte Antigens and Drug Hypersensitivity
• HLA-B*1502
• Mayo Test for HLA-B*1502
• HLA-B*5701
• Mayo Test for HLA-B*5701
• Summary
• Questions