Abstract
Herbal drugs are being in use for the management of human health and for prevention as well as to cure human diseases since ancient civilization. In recent days, the use of herbal drugs has been increased significantly in various forms such as herbal formulations, dietary supplements, and nutraceuticals in the global market. This growing demand undoubtedly proves the therapeutic claims of herbal drugs as biomedicines and/or functional foods. However, the safe use of herbal products/herbal medicines is still challenging due to the toxicity and regulatory issues. This review discusses toxicity-related and safety issues of herbal medicinal products, factors responsible for, and suitable remedial measures. Some challenges associated with monitoring the safety of herbal drugs are also discussed to ensure their effectiveness for adequate protection of public health and the relevant regulatory issues.
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Abbreviations
- CAM:
-
Complementary and alternative medicines
- CVS:
-
Cardiovascular system
- DSHEA:
-
Dietary Supplement Health and Education Act of 1994
- FDA:
-
Food and Drug Administration
- GC-MS:
-
Gas chromatography-mass spectrometry
- GMP:
-
Good manufacturing practices
- HMPs:
-
Herbal medicinal products
- LC-MS:
-
Liquid chromatography-mass spectrometry
- TM:
-
Traditional medicine
- WHO:
-
World Health Organization
References
Abubakar AR, Chedi BAZ, Mohammed KG, Haque M (2015) Drug interaction and its implication in clinical practice and personalized medicine. Natl J Physiol Pharm Pharmacol 5:343–349
Akerele O (1993) Summary of WHO guidelines for the assessment of herbal medicines. HerbalGram 28:13–19
Ang-Lee MK, Moss J, Yuan CS (2001) Herbal medicines and perioperative care. J Am Med Assoc 286:208–216
Bandaranayake WM (2006) Quality control, screening, toxicity, and regulation of herbal drugs modern Phytomedicine. In: Ahmad I, Aqil F, Owais M (eds) Turning medicinal plants into drugs. Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, pp 25–57
Bauer R, Tittel G (1996) Quality assessment of herbal preparations as a precondition of pharmacological and clinical studies. Phytomedicine 2:193–198
Bijauliya R, Alok S, Chanchal DK, Kumar M (2017) A comprehensive review on standardization of herbal drugs. Int J Pharm Sci Res 8:3663–3677
Bland SE (1998) Drug-food interactions. J Pharm Soc Wisconsin 14:S28–S35
Boullata JI, Nace AM (2000) Safety issues with herbal medicine. Pharmacotherapy 20:257–269
Bushra R, Aslam N, Khan AY (2011) Food-drug interactions. Oman Med J 26:77–83
Calixto JB (2000) Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents). Braz J Med Biol Res 33:179–189
Cordell GA, Colvard MD (2012) Natural products and traditional medicine: turning on a paradigm. J Nat Prod 75:514–525
Coxeter PD, McLachlan AJ, Duke CC, Roufogalis BD (2004) Herb-drug interactions: an evidence based approach. Curr Med Chem 11:1513–1525
Cragg GM, Newman DJ, Snader KM (1997) Natural products in drug discovery and development. J Nat Prod 60:52–60
D’Arcy PF (1993) Adverse reactions and interactions with herbal medicines. Part 2—drug interactions. Adverse Drug React Toxicol Rev 12:147–162
De Smet PAGM (1995) Health risks of herbal remedies. Drug Saf 13:81–93
De Smet PAGM (1997) The role of plant derived drugs and herbal medicines in healthcare. Drugs 54:801–840
Drew A, Myers SP (1997) Safety issues in herbal medicine: implications for the health professions. Med J Aust 166:538–541
Ekor M (2014) The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety. Front Pharmacol 4:1–10
Ernst E (2005) The efficacy of herbal medicine—an overview. Fundam Clin Pharmacol 19:405–409
Ernst E (2011) Herbal medicinal products: an overview of systematic reviews and meta-analyses. Perfusion 14:398–404
Fabricant DS, Farnsworth NR (2001) The value of plants used in traditional medicine for drug discovery. Environ Health Perspect 109:69–75
Farnsworth NR, Akerele O, Bingel AS, Soejarto DD, Guo Z (1985) Medicinal plants in therapy. Bull World Health Organ 63:965–981
Fetrow CW, Avila JR (2004) Professional’s handbook of complementary and alternative medicines. Lippincott Williams & Wilkins, Philadelphia
Fugh-Berman A, Ernst E (2001) Herb-drug interactions: review and assessment of report reliability. Br J Clin Pharmacol 52:587–595
Ganesan A (2008) The impact of natural products upon modern drug discovery. Curr Opin Chem Biol 12:306–317
George P (2011) Concerns regarding the safety and toxicity of medicinal plants—an overview. J Appl Pharm Sci 1:40–44
Herr SM, Ernst E, Young VSL (2002) Herb-drug interaction handbook. Church Street Books, New York
Izzo AA, Ernst E (2011) Interactions between herbal medicines and prescribed drugs: a systematic review. 15:2163–2175
Jamshidi-Kia F, Lorigooini Z, Amini-Khoei H (2018) Medicinal plants: past history and future perspective. J Herbmed Pharmacol 7:1–7
Kong JM, Goh NK, Chia LS, Chia TF (2003) Recent advances in traditional plant drugs and orchids. Acta Pharm Sin 24:7–21
Mukherjee PK, Harwansh RK, Bahadur S, Banerjee S, Kar A (2006) Evidence based validation of Indian traditional medicine—way forward. World J Tradit Chin Med 2:48–61
Mukherjee PK, Harwansh RK, Bahadur S (2013) Standardization and chemoprofiling of herbal medicine through marker analysis. Pharm Rev 58:161–163
Nasri H, Shirzad H (2012) Toxicity and safety of medicinal plants. J Herbmed Pharmacol 2:21–22
Nikam P, Kareparamban J, Jadhav A, Kadam V (2012) Future trends in standardization of herbal drugs. J Appl Pharm Sci 2:38–44
Otles S, Senturk A (2014) Food and drug interactions: a general review. Acta Sci Pol Technol Aliment 13:89–102
Pal SK, Shukla Y (2003) Herbal medicine: current status and the future. Asian J Cancer Prev 4:281–288
Parle M, Bansal N (2006) Herbal medicines: are they safe? Nat Prod Rad 5:6–14
Patra KC, Pareta SK, Harwansh RK, Kumar KJ (2012) Traditional approaches towards standardization of herbal medicines—a review. J Pharm Sci Technol 2:372–379
Roberts JE, Tyler VE (1997) Tyler’s herbs of choice. The therapeutic use of phytomedicinals. The Haworth Press, New York
Rodrigues E, Barnes J (2013) Pharmacovigilance of herbal medicines: the potential contributions of ethnobotanical and ethnopharmacological studies. Drug Saf 36:1–12
Saxena A, Tripathi KP, Roy S, Khan F, Sharma A (2008) Pharmacovigilance: effects of herbal components on human drugs interactions involving cytochrome P450. Bioinformation 3:198–204
Schulz V, Hänsel R, Tyler VE (2001) Rational phytotherapy. A physician’s guide to herbal medicine. Springer, Berlin
Shetti S, Kumar CD, Srivastava NK (2011) Pharmacovigilance of herbal medicines: current state and future directions. Pharmacogn Mag 7:69–73
Shukla SS, Saraf S, Saraf S (2009) Approaches towards standardization and quality assessment of herbals. J Res Edu Indian Med 15:25–32
Shulammithi R, Sharanya M, Tejaswini R, Kiranmai M (2016) Standardization and quality evaluation of herbal drugs. IOSR J Pharm Biol Sci 11:89–100
Staines SS (2011) Herbal medicines: adverse effects and drug-herb interactions. J Malta Coll Pharm Pract 11:38–42
Tasneem TSS (2012) Drug-herb interactions. Int J Pharmaceut Chem Biol Sci 3:75–78
Thomas AS, Varughese P, Shirwaikar A, Shirwaikar A (2012) Herb-drug interactions: a review. Hygeia J D Med 4:33–40
Warude D, Patwardhan B (2005) Botanicals: quality and regulatory issues. J Sci Ind Res 64:83–92
WHO (2004) WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems. World Health Organization, Geneva
WHO (2005a) WHO global atlas of traditional, complementary and alternative medicine. In: Ong CK, Bodek G, Grundy CB, Kin S (eds) . World Health Organization, Geneva
WHO (2005b) National Policy on traditional medicine and regulation of herbal medicines—report of a WHO global survey. World Health Organization, Geneva
Wu SK, Ghantous H, Birnkrant DB (2008) Current regulatory toxicology perspectives on the development of herbal medicines to prescription drug products in the United States. Food Chem Toxicol 46:2606–2610
Yuan H, Ma Q, Ye L, Piao G (2016) The traditional medicine and modern medicine from natural products. Molecules 21:1–18
Zhang J, Onakpoya IJ, Posadzki P, Eddouks M (2015) The safety of herbal medicine: from prejudice to evidence. Evid Based Complement Alternat Med 2015:316706
Zhi-Xu H, Thach C, Zhou SF (2014) Clinical herb-drug interactions as a safety concern in pharmacotherapy. J Pharmacol Drug Metab 1:1–3
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Rudrapal, M., Chetia, D. (2021). Herbal Drugs: Efficacy, Toxicity, and Safety Issues. In: Mandal, S.C., Chakraborty, R., Sen, S. (eds) Evidence Based Validation of Traditional Medicines. Springer, Singapore. https://doi.org/10.1007/978-981-15-8127-4_26
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