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Planta Med 2012; 78(13): 1400-1415
DOI: 10.1055/s-0032-1315145
Regulatory Affairs
Reviews
Georg Thieme Verlag KG Stuttgart · New York

Botanical-Drug Interactions: A Scientific Perspective

Manuela de Lima Toccafondo Vieira
1   Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA
,
Shiew-Mei Huang
1   Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA
› Author Affiliations
Further Information

Publication History

received 23 April 2012
revised 03 July 2012

accepted 06 July 2012

Publication Date:
03 August 2012 (online)

Also available at
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Abstract

There is a continued predisposition of concurrent use of drugs and botanical products. A general lack of knowledge of the interaction potential together with an under-reporting of botanical use poses a challenge for the health care providers and a safety concern for patients. Botanical-drug interactions increase the patient risk, especially with regard to drugs with a narrow therapeutic index (e.g., warfarin, cyclosporine, and digoxin). Examples of case reports and clinical studies evaluating botanical-drug interactions of commonly used botanicals in the US are presented. The potential pharmacokinetic and pharmacodynamic bases of such interactions are discussed, as well as the challenges associated with the interpretation of the available data and prediction of botanical-drug interactions. Recent FDA experiences with botanical products and interactions including labeling implications as a risk management strategy are highlighted.

Key words

drug-interactions - botanical products - regulatory science - clinical pharmacology

Supporting Information

 

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