A regulatory science viewpoint on botanical–drug interactions

• Main Authors: Manuela Grimstein, Shiew-Mei Huang
• Format: Article
• Language: English
• Published: Elsevier 2018-04-01
• Series: Journal of Food and Drug Analysis
• Online Access: http://www.sciencedirect.com/science/article/pii/S1021949818300425

There is a continued predisposition of concurrent use of drugs and botanical products. Consumers often self-administer botanical products without informing their health care providers. The perceived safety of botanical products with lack of knowledge of the interaction potential poses a challenge for providers and both efficacy and safety concerns for patients. Botanical–drug combinations can produce untoward effects when botanical constituents modulate drug metabolizing enzymes and/or transporters impacting the systemic or tissue exposure of concomitant drugs. Examples of pertinent scientific literature evaluating the interaction potential of commonly used botanicals in the US are discussed. Current methodologies that can be applied to advance our efforts in predicting drug interaction liability is presented. This review also highlights the regulatory science viewpoint on botanical–drug interactions and labeling implications. Keywords: Drug interaction, Botanical product, St. John's wort, Fruit juices, Regulatory science