A regulatory science viewpoint on botanical-drug interactions

Area of Science:

• Pharmacology
• Natural Products Chemistry
• Drug Metabolism

Background:

• Consumers frequently use botanical products alongside conventional drugs.
• Self-administration without provider notification creates safety challenges.
• Lack of awareness regarding botanical-drug interactions impacts patient care.

Purpose of the Study:

• To review the interaction potential of commonly used botanical products in the US.
• To discuss methodologies for predicting botanical-drug interaction liability.
• To highlight regulatory science and labeling considerations for botanical-drug interactions.

Main Methods:

• Review of scientific literature on botanical-drug interactions.
• Discussion of methodologies for predicting interaction potential.
• Analysis of regulatory science and labeling implications.

Main Results:

• Botanical constituents can modulate drug metabolizing enzymes and transporters.
• These modulations can alter systemic or tissue drug exposure.
• Examples of interactions with common US botanicals are presented.

Conclusions:

• Botanical-drug interactions present significant efficacy and safety concerns.
• Predictive methodologies are advancing the understanding of interaction liability.
• Clearer labeling and regulatory oversight are needed for botanical products.