Affiliations: Research Institute for Medicines and Pharmaceutical Sciences (iMed.ULisboa), Pharmacological Sciences Group, Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal
Correspondence:
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Correspondence to: Kamila Gromek, Research Institute for Medicines (iMed.ULisboa), Faculty of Pharmacy, Universidade de Lisboa, Department of Pharmacological Sciences, Laboratory of Pharmacognosy, Av. Prof. Gama Pinto, 1649-003 Lisbon, Portugal. Tel.: +351 217946400/14607; [email protected]
Abstract: The importance of herbal remedies in pharmacovigilance systems is becoming one of the primary tasks, due to the constantly ascending potential of herbal products and herbal medicines worldwide. Nowadays, the drug development is focused on finding new active compounds or combinations, but costs are simultaneously growing, which makes herbal medicines an attractive, harmless and cheaper alternative to synthetic drugs. Like all drugs, herbal are not free of risk and many studies suggest for potential adverse reactions and interactions. Available statistics show that some herbal products, used in traditional medication for generations, may possess carcinogenic, hepatotoxic, cardiotoxic and other severe actions. Evaluation of the safety 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 in some cases and examination of the effects on drug-metabolizing enzymes. Drug safety of herbal medicines should be developed, focusing on specific groups of patients.
Keywords: Herbal drugs, pharmacovigilance, quality control, drug safety, traditional medicine, alternative medicine
