Safety of Medicinal Tropical Natural Products – Concerns and Issues
Background: No medicinal product is safe whether it is of streamline medicine or belongs to traditional system of medicine. Tropical products of natural drugs, fruits and supplements, no matter how common it’s clinical uses, have the potential to cause harm. It is true that adverse reactions are a cost of modern medical therapy, but indigenous drugs used in traditional medicines especially herbs and tropical products are also not safe in true sense. In addition, in recent years, there have been several other high-profile herbal safety concerns that have had an impact on the public health, and there is increasing recognition of the need to develop Pharmacovigilance systems for medicinal herbs and tropical products.
Methods: Pharmacovigilance should be a priority for every country with a public health disease. The focused Pharmacovigilance initiatives for the safe treatment of tropical diseases such as malaria, leishmaniasis and schistosomiasis, involving the administration of medicines to large communities are being implemented within the same population with little knowledge of, or regard to, how these various medicines could interact with each other. Moreover, Pharmacovigilance approach to tropical herbal products including natural substances and supplements and monitoring the safety of herbal medicines presents unique challenges.
Results: This paper aims to provide a critical overview of the current state of Pharmacovigilance activities for some tropical diseases and herbal tropical medicines at the national and global levels. It will explore in depth the challenges that Pharmacovigilance of herbal medicines presents, consider relevant emerging issues and what steps could be taken to improve the safety monitoring for herbal medicines in the future.
Conclusion: Pharmacovigilance practices for herbal medicine are different from that of conventional drugs. The existing systems developed for synthetic medicines and
require some modifications to address specific differences of herbal medicines including medicinal products of tropical natural drugs, fruits and supplements. It also needs to be implemented to find and remove secondary toxic metabolites in tropical foods.
2. Hume, Anne and Strong, Kathryn. Botanical Medicines. In: Berardi R, Kroon L, Newton G, et al, eds. Handbook of Nonprescription Drugs.15th Edition. Washington, DC: American Pharmacists Association 2006:1104-1136.
3. Dermatological Disorders. In: Beers M, ed: The Merck Manual of Diagnosis and Therapy.18th Edition. Rahway, NJ: Merck Publishing 2006:2724-2728.
4. Rahman SZ, Basilakis J, Rahmadi A, Lujic S, Musgrave I, Jorm L, Hay P, Münch G. Use of serotonergic antidepressants and St John’s wort in older Australians: a population-based cohort study. Australasian Psychiatry 2013; 21(3):262-6.
5. Barnes J, Anderson LA, Phillipson JD, Newall CA. Herbal medicines. London: pharmaceutical press; 2007.
6. Hidaka M, Fujita KI, Ogikubo T, Yamasaki K, Iwakiri T, Okumura M, Kodama H, Arimori K. Potent inhibition by star fruit of human cytochrome P450 3A(CYP3A) activity. Drug metabolism and disposition 2004; 32(6):581-3
7. Hidaka M, Nagata M, Kawano Y, Sekiya H, Kai H, Yamasaki K, Okumura M, Arimori K. Inhibitory effects of fruit juices on cytochrome P450 2C9 activity in vitro. Bioscience, Biotechnology and Biochemistry 2008; 23; 72(2):406-11.
8. Pierson JT, Dietzgen RG, Shaw PN, Roberts‐Thomson SJ, Monteith GR, Gidley MJ. Major Australian tropical fruits biodiversity: Bioactive compounds and their bioactivities. Molecular nutrition & food research 2012; 56(3):357-87.
9. Chen M, Zhou SY, Fabriaga E, Zhang PH, Zhou Q. Food-drug interactions precipitated by fruit juices other than grapefruit juice: An update review. Journal of food and drug analysis 2018 Apr 1;26(2):S61-71.
10. Terrie YC. THE EDUCATED PATIENT-Using Herbal Supplements Safely. Pharmacy Times 2012;78(3):70.
11. Haïdara K, Zamir L, Shi QW, Batist G. The flavonoid Casticin has multiple mechanisms of tumour cytotoxicity action. Cancer letters 2006; 242(2):180-90.
12. Hajda J, Rentsch KM, Gubler C, Steinert H, Stieger B, Fattinger K. Garlic extract induces intestinal P-glycoprotein, but exhibits no effect on intestinal and hepatic CYP3A4 in humans. European journal of pharmaceutical sciences 2010; 41(5):729-35.
13. Graber-Maier A, Büter KB, Aeschlimann J, Bittel C, Kreuter M, Drewe J, Gutmann H. Effects of Curcuma extracts and curcuminoids on expression of P-glycoprotein and cytochrome P450 3A4 in the intestinal cell culture model LS180. Planta medica 2010; 76(16):1866-70.
14. Latif A & Rahman SZ. A Serious Adverse Drug Interaction of two Traditional Medicines - A Case Report. J Pharmacovigilance Drug Safety 2005; 2: 26-29
15. Latif A, Rahman SZ & Singhal KC. Adverse Drug Reactions of an herbal drug due to Mis-identification - A Case Report. J Pharmacovigilance Drug Safety 2004; 1: 16-18
16. Yamamoto A, Sudo H, Endo A. Therapeutic effects of ML-236B in primary hypercholesterolemia. Atherosclerosis 1980;35(3):259-66.
17. Wei W., et al. Hypolipidemic and anti-atherogenic effects of long-term cholestin (Monascus purpreus fermented rice, red yeast rice) in cholesterol fed rabbits. J.Nutr.Biochem 2003; 14, 314-318.
18. Chang JC, Wu MC, Liu IM, Cheng JT. Plasma glucose-lowering action of Hon-Chi in streptozotocin-induced diabetic rats. Hormone and Metabolic Research 2006;38(02):76-81.
19. Wong Ricky W.K., Rabie. Chinese red yeast rice (Monascus purpureus-fermented rice) promotes bone formation, Chin. Med. 2008; 3, 4-6.
20. Lee CL, Kuo TF, Wang JJ, Pan TM. Red mold rice ameliorates impairment of memory and learning ability in intracerebroventricular amyloid β‐infused rat by repressing amyloid β accumulation. Journal of neuroscience research 2007; 85(14):3171-82.
21. Ho BY, Wu YM, Hsu YW, Hsu LC, Kuo YH, Chang KJ, Pan TM. Effects of Monascus-Fermented Rice Extract on Malignant Cell—Associated Neovascularization and Intravasation Determined Using the Chicken Embryo Chorioallantoic Membrane Model. Integrative cancer therapies 2010; 9(2):204-12.
22. Ukomadu C, Dutta A. p21-dependent inhibition of colon cancer cell growth by mevastatin is independent of inhibition of G1 cyclin-dependent kinases. Journal of Biological Chemistry 2003; 278(44): 43586-94.
23. Ciegler A, Vesonder RF, Jackson LK. Produciton and biological activity of patulin and citrinin from Penicillium expansum. Appl. Environ. Microbiol. 1977; 33(4):1004-6
24. Chagas GM, Oliveria MBM, Campello AP, Kluppel M. Mechanism of citrinin-induced dysfunction of mitochondria.2. Effect on respiration, enzyme-activities, and membrane-potential of liver-mitochondria. Cell Biochem Funct. 1992; 10,209-216.
25. The Ministry of Health and Welfare of Japan (2000). Monascus color. Japan’s specifications and standards for food additives (7th edn.), Sect. D257.
26. Lalli CA, Pauli JR, Prada PO, Cintra DE, Ropelle ER, Velloso LA, Saad MJ. Statin modulates insulin signaling and insulin resistance in liver and muscle of rats fed a high-fat diet. Metabolism 2008; 57(1):57-65.
27. Dutt P, Hasan M, Shaququzzaman M, Panda BP. Quality assessment of Indian rice varieties, evaluation of its relationship with their Glycaemic index. Journal of Food Measurement and Characterization 2019; 13(3):2389-97.
Copyright (c) 2020 Syed Ziaur Rehman, Sulthan Al Rashid
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.