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Drug-Drug, Drug-Dietary Supplement, and Drug-Citrus Fruit and Other Food Interactions: What Have We Learned?

From the Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, Rockville, MD 20850.

Serious drug-drug interactions have contributed to recent U.S. market withdrawals and also recent nonapprovals of a few new molecular entities. Many of these interactions involved the inhibition or induction of metabolizing enzymes and efflux transporters, resulting in altered systemic exposure and adverse drug reactions or loss of efficacy. In addition to drug-drug interactions, drug-dietary supplement and drug-citrus fruit interactions, among others, could also cause adverse drug reactions or loss of efficacy and are important issues to consider in the evaluation of new drug candidates. This commentary reviews (1) the current understanding of the mechanistic basis of these interactions, (2) issues to consider in the interpretation of study results, and (3) recent labeling examples to illustrate the translation of study results to information useful for patients and health care providers.

Key Words: Drug-drug interaction • drug-dietary supplement interaction • drug-juice interaction • drug development • exposure-response relationship • labeling • risk management

Address for reprints: Shiew-Mei Huang, PhD, Office of Clinical Pharmacology and Biopharmaceutics, HFD-850, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, PKLN 6A/19, Rockville, MD 20850.

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