Herbal Supplements-Drug Interactions: Scientific and Regulatory Perspectives

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ISBN: 9780824725389 | 0824725387
Cover: Hardcover
Copyright: 6/7/2006

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Written by seasoned authorities in the field, this reference uses reliable, peer-reviewed data to present a vast array of herb-drug interactions, the mechanisms behind these interactions, and the clinical significance of these interactions--offering specific sections on individual herbs, commonly consumed Chinese herbs, and regulatory issues.

Preface

iii

Contributors

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

(6)

Safety of Botanical Products

(11)

Conclusions 19 References

(6)

2. Drug Interactions with Botanical Products

(24)

Y.W. Francis Lam, Shiew-Mei Huang, and Stephen D. Hall

Overview of Botanical–Drug Interactions

(1)

Mechanisms of Botanical–Drug Interactions

(1)

Altered Pharmacokinetics

(7)

Altered Pharmacodynamics

(3)

Antagonistic Pharmacodynamic Effect

(1)

Evaluating Botanical–Drug Interaction

(3)

Confounding Issues Related to Study Design

(1)

Future

(1)

References

(6)

3. In Vitro Inhibition with Botanical Products

(20)

Brian C. Foster, John T. Arnason, and Colin J. Briggs

Background

(1)

Natural Product Variation

(12)

Test Conditions

(1)

Product Selection for Clinical Studies

(1)

Conclusion

(1)

References

(4)

4. Drug Interactions with St. John's Wort and Echinacea

(38)

J. Christopher Gorski

Introduction

(1)

St. John's Wort

(22)

Echinacea

(3)

References

(12)

5. Botanical Products–Drug Interactions: Focus on Garlic, Ginkgo and Ginseng

107

(16)

Y.W. Francis Lam and E. Ernst

Introduction

107

(1)

Garlic (Album Sativum L.)

108

(4)

Ginkgo (Ginkgo Biloba L.)

112

(3)

Asian Ginseng (Pantry Ginseng C.A. Meyer)

115

(3)

Comment

118

(1)

References

119

(4)

6. A Review of Chinese Botanical Product–Drug Interactions

123

(24)

Y.W. Francis Lam and Ming Ou

Introduction

123

(2)

Chinese Botanical Products and Warfarin

125

(8)

Chinese Botanical Products and Phenprocoumon

133

(1)

Chinese Botanical Products and Aspirin

134

(2)

Chinese Botanical Products and Digoxin

136

(1)

Chinese Botanical Products and Digoxin-like Immunoreactivity

137

(1)

Limitations of Current Literature

137

(1)

Specific Issues Regarding Evaluation of Chinese Botanical Product–Drug Interactions

138

(5)

Conclusion

143

(1)

References

143

(4)

7. Drug Interactions of Grapefruit and Other Citrus—What Have We Learned?

147

(44)

S.U. Mertens-Talcott, I. Zadezensky, W.V. De Castro, Veronika Butterweck, and Hartmut Derendorf

Introduction

147

(2)

Phenolic Compounds in Grapefruit and Citrus with Potential Drug Interactions

149

(4)

Possible Mechanisms of Interaction

153

(6)

Classes of Drugs Interacting with GFJ

159

(17)

Conclusions

176

(1)

Future Directives

177

(1)

References

178

(13)

8. Quality Assurance and Standardization in Botanical Product–Drug Interaction: Evaluation and Documentation

191

(14)

Lucas R. Chadwick and Harry H.S. Fong

Introduction

191

(2)

Material Quality and Quality Control Issues

193

(1)

Intrinsic and Extrinsic Factors

194

(2)

Regulatory Influence

196

(1)

Quality Assurance and Quality Control

197

(3)

Clinical Experimental Design and Data Interpretation

200

(1)

Conclusion

200

(1)

References

201

(4)

9. Pharmacokinetics of Botanical Products

205

(40)

Veronika Butterweck and Hartmut Derendorf

Introduction

205

(2)

Ginkgo Biloba

207

(6)

St. John's Wort

213

(8)

Garlic

221

(3)

Willow Bark

224

(2)

Horse Chestnut

226

(2)

Ginseng

228

(3)

Milk Thistle

231

(4)

Conclusion

235

(1)

References

235

(10)

10. Drug–Drug, Drug–Dietary Supplement, Drug–Citrus Fruit, and Other Food Interactions—Labeling Implications

245

(30)

Shiew-Mei Huang, Lawrence J. Lesko, and Robert Temple

Introduction

245

(1)

Metabolism of New Molecular Entities and Interactions with Other Drugs

245

(7)

Effect of Dietary Supplements on New Molecular Entities and Interactions

252

(7)

Effect of Citrus Fruit/Fruit Juice on New Molecular Entities

259

(12)

Conclusions

271

(1)

References

272

(3)

11. FDA Perspectives on the Use of Postmarketing Reporting Systems to Evaluate Drug Interactions with CAHP

275

(10)

Lori A. Love

Introduction

275

(1)

Regulatory Classification of Botanical Products

276

(1)

Safety Concerns Related to Botanicals

277

(1)

Identification and Evaluation of Potential Product Interactions

278

(1)

Adverse Event Reporting at FDA: The Medwatch Program

278

(2)

Adverse Events and Risk Management

280

(1)

References

281

(4)

12. St. John's Wort Drug Interaction Reports from FDA's Postmarketing AERS

285

(8)

Min-Chu Chen

Introduction

285

(1)

Drug Interactions with St. John's Wort

286

(5)

Conclusion

291

(1)

References

292

(1)

13. Grapefruit Juice Interaction Reports from FDA's Postmarketing AERS

293

(10)

Toni Piazza-Hepp

Introduction

293

(1)

Spontaneous Adverse Event Case Reports

293

(4)

Case Reports Compared to Labeling

297

(3)

Plausibility of Drug—Grapefruit Juice Interaction

300

(1)

Conclusion

301

(1)

References

301

(2)

14. Botanicals as Drugs: A U.S. Perspective

303

(16)

Freddie Ann Hoffman

Introduction

303

(2)

Regulatory Options

305

(1)

Historical Perspective

305

(3)

Complementary and Alternative Medicine

308

(1)

A New Regulatory Paradigm

309

(1)

Selecting a Route to Market

310

(1)

Intended Use

311

(1)

Advantages of the Drug Route

311

(2)

Cost

313

(1)

Whole Is Greater than the Parts

314

(1)

References

315

(4)

15. Development of Botanical Products as Pharmaceutical Agents

319

(8)

Shaw T. Chen

Introduction

319

(1)

The Regulatory Objectives

320

(1)

The Distinctive Features of Botanicals

320

(1)

The Botanical Guidance

321

(1)

Botanical Review Team in Center for Drug Evaluation and Research.

322

(1)

Review Processes for Botanical Applications

323

(1)

Botanical Drug Applications in Center for Drug Evaluation and Research

324

(1)

Challenges in the Review of Botanical Drug Applications

325

(1)

Prospects of Further Development

326

(1)

Reference

326

(1)

Index

327

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Herbal Supplements-Drug Interactions: Scientific and Regulatory Perspectives

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