Herbal Supplements- Drug Interactions

Transcription

1 Herbal Supplements- Drug Interactions Scientifle and Regulatory Perspectives edited by Y. W. Francis Lam University of Texas Health Science Center San Antonio, Texas, U.S.A. Shiew-Mei Huang FDA Center for Drug Evaluation and Research Silver Spring, Maryland, U.S.A. Stephen D. Hall Indiana University School of Medicine Wishard Memorial Hospital Indianapolis, Indiana, U.S.A. Taylor & Francis Taylor Si Francis Group New York London Taylor & Francis is an imprint of the Taylor 6t Francis Croup, an informa business

2 Contents Preface... Hi Contributors... xi 1. The Landscape of Botanical Medicine Utilization and Safety / Andrew Morris and Michael D. Murray Introduction... 1 Utilization of Botanical Dietary Supplements in the United States... 2 Safety of Botanical Products... 8 Conclusions References Drug Interactions with Botanical Products 25 Y. W. Francis Lam, Shiew-Mei Huang, and Stephen D. Hall Overview of Botanical-Drug Interactions Mechanisms of Botanical-Drug Interactions Altered Pharmacokinetics Altered Pharmacodynamics Antagonistic Pharmacodynamic Effect Evaluating Botanical-Drug Interaction Confounding Issues Related to Study Design Future References... 43

3 v] Contents 3. In Vitro Inhibition with Botanical Products 49 Brian C. Foster, John T. Arnason, and Colin J. Briggs Background Natural Product Variation Test Conditions Product Selection for Clinical Studies Conclusion References Drug Interactions with St. John's Wort and Echinacea 69 J. Christopher Gorski Introduction St. John's Wort Echinacea References Botanical Products-Drug Interactions: Focus on Garlic, Ginkgo and Ginseng 107 Y. W. Francis Lam and E. Ernst Introduction Garlic (Allium Sativum L.) Ginkgo (Ginkgo Biloba L.) Asian Ginseng (Panax Ginseng C. A. Meyer) Comment References A Review of Chinese Botanical Product-Drug Interactions 123 Y. W. Francis Lam and Ming Ou Introduction Chinese Botanical Products and Warfarin Chinese Botanical Products and Phenprocoumon Chinese Botanical Products and Aspirin Chinese Botanical Products and Digoxin Chinese Botanical Products and Digoxin-like Immunoreactivity Limitations of Current Literature Specific Issues Regarding Evaluation of Chinese Botanical Product-Drug Interactions

4 Contents vii Conclusion References Drug Interactions of Grapefruit and Other Citrus What Have We Learned? 147 S. U. Mertens-Talcott, I. Zadezensky, W. V. De Castro, Veronika Butterweck, and Hartmut Derendorf Introduction Phenolic Compounds in Grapefruit and Citrus with Potential Drug Interactions Possible Mechanisms of Interaction Classes of Drugs Interacting with GFJ Conclusions Future Directives References Quality Assurance and Standardization in Botanical Product-Drug Interaction: Evaluation and Documentation 191 Lucas R. Chadwick and Harry H. S. Fong Introduction Material Quality and Quality Control Issues Intrinsic and Extrinsic Factors Regulatory Influence Quality Assurance and Quality Control Clinical Experimental Design and Data Interpretation Conclusion References Pharmacokinetics of Botanical Products 205 Veronika Butterweck and Hartmut Derendorf Introduction Ginkgo Biloba St. John's Wort Garlic Willow Bark Horse Chestnut Ginseng Milk Thistle Conclusion References

5 yjjj Contents 10. Drug-Drug, Drug-Dietary Supplement, Drug-Citrus Fruit, and Other Food Interactions Labeling Implications 245 Shiew-Mei Huang, Lawrence J. Lesko, and Robert Temple Introduction Metabolism of New Molecular Entities and Interactions with Other Drugs Effect of Dietary Supplements on New Molecular Entities and Interactions Effect of Citrus Fruit/Fruit Juice on New Molecular Entities Conclusions References FDA Perspectives on the Use of Postmarketing Reporting Systems to Evaluate Drug Interactions with CAHP 275 Lori A. Love Introduction Regulatory Classification of Botanical Products Safety Concerns Related to Botanicals Identification and Evaluation of Potential Product Interactions Adverse Event Reporting at FDA: The Medwatch Program Adverse Events and Risk Management References St. John's Wort Drug Interaction Reports from FDA's Postmarketing AERS 285 Min-Chu Chen Introduction Drug Interactions with St. John's Wort Conclusion References Grapefruit Juice Interaction Reports from FDA's Postmarketing AERS 293 Toni Piazza-Hepp Introduction Spontaneous Adverse Event Case Reports Case Reports Compared to Labeling

6 Contents ix Plausibility of Drug-Grapefruit Juice Interaction Conclusion References Botanicals as Drugs: A U.S. Perspective 303 Freddie Ann Hoffman Introduction Regulatory Options Historical Perspective Complementary and Alternative Medicine A New Regulatory Paradigm Selecting a Route to Market Intended Use Advantages of the Drug Route Cost Whole Is Greater than the Parts References Development of Botanical Products as Pharmaceutical Agents 319 Shaw T. Chen Introduction The Regulatory Objectives The Distinctive Features of Botanicals The Botanical Guidance Botanical Review Team in Center for Drug Evaluation and Research Review Processes for Botanical Applications Botanical Drug Applications in Center for Drug Evaluation and Research Challenges in the Review of Botanical Drug Applications Prospects of Further Development Reference Index