Traditional use and safety of herbal medicines

Revista Brasileira de Farmacognosia

De-Oliveira, Ana Cecilia A.X.¹  Moreira, Davyson de L.¹  Monteiro, Maria Helena D.¹  Paumgartten, Francisco J.R.¹  Teixeira, Sabrina Schaaf¹ 

关键词: Phytotherapy;    Medicinal plant;    Evidence-based medicine;    Hepatotoxicity;    Carcinogenicity;    Pharmacovigilance;   

DOI  :  10.1016/j.bjp.2014.03.006

来源: Sociedade Brasileira de Farmacognosia

【 摘 要 】

In the European Union, traditional herbal medicines that are regarded as "acceptably safe, albeit not having a recognized level of efficacy" fit into a special category of drugs ("traditional herbal medicine products") for which requirements of non-clinical and clinical studies are less rigorous. A regulation proposal published by the Brazilian National Health Surveillance (Anvisa) defines a similar drug category ("traditional phytotherapeutic products") for registration purposes. Regarding herbal medicines, both agencies seem to be lenient regarding proof of efficacy, and consider long-standing folk use as evidence of safety and a waiver of a thorough toxicological evaluation. Nonetheless, several herbal products and constituents with a long history of folk usage are suspected carcinogenic and/or hepatotoxic. Herbal products have also been shown to inhibit and/or induce drug-metabolizing enzymes. Since herbal medicines are often used in conjunction with conventional drugs, kinetic and clinical interactions are a cause for concern. A demonstration of the safety of herbal medicines for registration purposes should include at least in vitro and in vivo genotoxicity assays, long-term rodent carcinogenicity tests (for drugs intended to be continuously used for > 3 months or intermittently for > 6 months), reproductive and developmental toxicity studies (for drugs used by women of childbearing age), and investigation of the effects on drug-metabolizing enzymes.

【 授权许可】

Unknown