Cross matching observations on toxicological and clinical data for the assessment of tolerability and safety of Ginkgo biloba leaf extract

• Published in: Toxicology (Amsterdam) Vol. 327; pp. 95 - 115
• Main Authors: Heinonen, Tuula, Gaus, Wilhelm
• Format: Journal Article
• Language: English
• Published: Ireland Elsevier B.V 02-01-2015
• Subjects: Adverse drug reaction; Animals; Carcinogenicity; Clinical studies; Cross matching; EGb761®, CAS 122933-57-7; Emergency; Ginkgo biloba; Ginkgo biloba - chemistry; Humans; Mice; Plant Extracts - pharmacokinetics; Plant Extracts - pharmacology; Plant Extracts - toxicity; Rats; glutathione-S-transferase; UDP-glucuronosyltransferase; ADME; EGb761; AhR; pregnane X receptor; cytochrome P-450; PXR; Adverse drug reaction; GSH-transferase; Ginkgo biloba extract, CAS 122933-57-7; aryl hydrocarbon receptor; Ginkgo biloba; uridine 5′-diphospho-glucuronosyltransferase; CAR; constitutive androstane receptor; CYP; absorption, distribution, metabolism, excretion; Cross matching; EGb761 ®, CAS 122933-57-7; Carcinogenicity; Clinical studies; EGb761®, CAS 122933-57-7; EGb761(®), CAS 122933-57-7
• ISSN: 0300-483X; 1879-3185
• DOI: 10.1016/j.tox.2014.10.013

Highlights • Cross-matching of toxicological, clinical and other data improves risk analysis. • Induction of drug metabolism is linked to increased cell proliferation. • Rodents and man have differences in metabolism of Ginkgo biloba. • Controlled clinical data did not reveal any serious or specific adverse drug reaction. • Cross-matching of various sources gives strong evidence that G. biloba is safe.