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Investigation of the Effects of Herbal Medicines on Warfarin Response in Healthy Subjects: A Population Pharmacokinetic-Pharmacodynamic Modeling Approach

From the Faculty of Pharmacy, the University of Sydney, Australia (Dr Jiang, Dr Blair, Dr McLachlan); the Department of Medicine, University of Chicago, Chicago, Illinois (Dr Jiang); the Centre for Education and Research on Ageing, Concord Repatriation General Hospital, Concord, Australia (Dr McLachlan); and Sanofi-Aventis, Sydney, Australia (Dr Blair).

Systematic evidence regarding herb-drug interactions is lacking. This study investigated herb-drug interactions with warfarin. S-warfarin concentration and response (prothrombin complex activity) data from healthy subjects (n = 24) who received a single warfarin dose (25 mg) and either St John's wort, Asian ginseng, Ginkgo biloba, or ginger were analyzed using a population pharmacokinetic-pharmacodynamic modeling approach. The ratio of S-warfarin apparent clearance (CL/F) compared to control was 1.39 ± 0.06 and 1.14 ± 0.04 after St John's wort and Asian ginseng pretreatment, respectively. Other pharmacokinetic and pharmacodynamic parameters were unaffected. Coadministration of St John's wort significantly increased S-warfarin CL/F, whereas treatment with Asian ginseng produced only a moderate increase in CL/F. Ginkgo and ginger did not affect the pharmacokinetics of warfarin in healthy subjects. None of the herbs studied had a direct effect on warfarin pharmacodynamics. Studies in anticoagulated patients are warranted to assess the clinical significance of these herb-drug interactions.

Key Words: Warfarin • anticoagulants • herb-drug interactions • St John's wort • Asian ginseng • ginkgo • ginger • population pharmacokinetic-pharmacodynamic modeling

Address for reprints: Professor Andrew J. McLachlan, PhD, Faculty of Pharmacy, Building A15, the University of Sydney, NSW 2006, Australia; e-mail: andrewm{at}pharm.usyd.edu.au.

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