2017, Number 1
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Rev Cubana Plant Med 2017; 22 (1)
Importance of pharmacovigilance in herbal medicine
Gruszycki KMR, Tauguinas PAL, Baez CM, Alba DDA, Gruszycki KAE
Language: Spanish
References: 30
Page: 1-10
PDF size: 148.86 Kb.
ABSTRACT
Introduction: Ever since ancient times medicinal herbs have been used to prevent
and treat a variety of diseases. Despite the beneficial traditional role of medicinal
herbs in various communities, their potential for causing adverse reactions and
toxicity should also be borne in mind.
Objective: Analyze the reports of adverse reactions by herbal medicinal products
issued from 2010 to 2016 in the province of Chaco, Argentina.
Methods: A descriptive cross-sectional retrospective study was conducted to
evaluate the reports of adverse reactions received from pharmacies and healthcare
institutions from the province of Chaco, Argentina, at the National System of
Pharmacovigilance of the National Drug, Food and Medical Technology
Administration (ANMAT). The study was based on official forms for the report
adverse events caused by the use of phytotherapeutic drugs, plant products and/or
plant drug preparations.
Results: A total 129 reports were received. Adverse reactions caused by the use of
herbal medicinal products prevailed in the female gender, whereas a large
percentage affected infants and children. Paico (Chenopodium ambrosioides L.) was
the species most commonly reported in this age group and sen (Cassia angustifolia
Vahl.) among adults. Most of the adverse reactions reported were gastrointestinal
disorders. As to intensity and imputability, there was a predominance of mild and
probable reactions, respectively.
Conclusions: Permanent vigilance of herbal medicines is crucial to promote their
safe use, particularly in vulnerable populations.
REFERENCES
Ekor M. The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety. Front. Pharmacol. 2014. [citado 7 feb 2016]. Disponible en: http://dx.doi.org.sci-hub.io/10.3389/fphar.2013.00177
Yogyata SP, Vijay DW. Herbal Medicines and Nutritional supplements used in the treatment of Glaucoma: A Review. RJPBCS. 2012. [citado 20 feb 2016];3(1):331-9. Disponible en: http://www.rjpbcs.com/pdf/2012_3(1)/42.pdf
Mazzari AL, Prieto JM. Herbal medicines in Brazil: pharmacokinetic profile and potential herb-drug interactions. Front. Pharmacol 2014;5(162):1-12. Disponible en: http://www.frontiersin.org/journal/ 10.3389/fphar.2014.00162/abstract
World Health Organization. WHO Guidelines on safety monitoring of herbal medicines in pharmacovigilance systems. Geneva WHO. 2004 [citado nov 2016]. Disponible en: http://www.who.int/patientsafety/events/05/Reporting_Guidelines.pdf
Awodele O, Daniel A, Popoola TD, Salami EF. A study on pharmacovigilance of herbal medicines in Lagos West Senatorial District, Nigeria. JRS in Med. 2013 [citado mar 2016];205-17. DOI 10.3233/JRS-130604.
García AJ, Avila Y, Alonso L, López P, Ruiz AK, Morón F. Reacciones adversas reportadas por consumo de productos naturales en Cuba durante 2003 y 2007. Rev Cubana Plant Med. 2009. [citado nov 2012];14(1). Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1028-47962009000100002
Organización Mundial de la Salud. Estrategia de la OMS sobre medicina tradicional 2014-2023. Hong Kong China. 2013. Disponible en: http://apps.who.int/medicinedocs/documents/s21201es/s21201es.pdf
Ministerio de Salud. Secretaría de Políticas, Regulación e Institutos. A.N.M.A.T. Guía de Buenas Prácticas de Farmacovigilancia. 2009. Buenos Aires: A.N.M.A.T.; 2009 [citado 15 feb 2016]. Disponible en: http://www.anmat.gov.ar/farmaco/GUIA_BPFV.pdf
Ministerio de Salud. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica. ANMAT. Informe anual 2012 del Departamento de Farmacovigilancia. 2012 [citado 6 feb 2016]. Disponible en: http://www.anmat.gov.ar/farmacovigilancia/docs/Informe_2012.pdf
Shaw D, Ladds G, Duez P, Williamson E, Chan K. Pharmacovigilance of herbal medicine. J Ethnopharmacol. 2012;140(3):513-8.
Neergheen-Bhujun VS. Underestimating the Toxicological Challenges Associated with the Use of Herbal Medicinal Products in Developing Countries. Biomed Res Int. 2013;2013:804086. doi: 10.1155/2013/804086. Epub 2013 Sep 19.
Raynor DK, Dickinson R, Knapp P, Long AF, Nicolson DJ. Buyer beware? Does the information provided with herbal products available over the counter enable safe use? BMC Medicine. 2011;9(94). doi: 10.1186/1741-7015-9-94.
Ministerio de Salud. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica. ANMAT. Efectores Periféricos del Sistema Nacional de Farmacovigilancia Año 2013. Disponible en: http://www.anmat.gob.ar/listados/Listado_efectores_perifericos_FVG.pdf
Zhou J, Ouedraogo M, Qu F, Duez P. Potential genotoxicity of traditional Chinese medicinal plants and phytochemicals: an overview. Phytother Res. 2013;27(12):1745-55. doi: 10.1002/ptr.4942
The Uppsala Monitoring Centre. Guidelines for Herbal ATC Classification. Uppsala, Sweden. WHO Colaborating Centre for International Drug Monitoring. 2004.
WHO International monitoring of adverse reactions to drugs: adverse reaction terminology. WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden. 1992.
Marinoff M, Martínez J, Urbina M. Precauciones en el empleo de plantas medicinales. BLACPMA. 2009 [citado 16 abr 2016];8(3):184-7. Disponible en: http://www.redalyc.org/pdf/856/85611774014.pdf
Woolf AD. Herbal Remedies and Children: Do They Work? Are They Harmful? Pediatrics. 2003;112(1 Pt 2):240-6.
Jiménez G, Debesa F, González B, Ávila J, Pérez J. El Sistema Cubano de Farmacovigilancia; seis años de experiencia en la detección de efectos adversos. Rev Cubana Farm. 2006 [citado 11 sept 2016];40(1). Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75152006000100002
Lorenzo P, Moreno A, Lizasoain I, Leza JC, Moro MA, Portolés A. Velázquez Farmacología Básica y Clínica. 18 aed. Madrid. Editorial Médica Panamericana. 2010.
Scarpa G. Medicinal plants used by the Criollos of Northwestern Argentine Chaco. J Ethnopharmacol. 2004;91(1):115-35.
Ávila J, Jiménez G, González B, Morón F, Fernández R. Reacciones adversas a medicamentos herbarios y otras formas de medicina natural y tradicional en Cuba durante 2001-2004. Rev Cubana Plant Med. 2008 [citado 21 jul 2016];13(1). Disponible http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S1028- 47962008000100003
Alonso J. Tratado de Fitofármacos y Nutracéuticos. 1aed. Buenos Aires, Argentina. Editorial Corpus; 2008.
Tisserand R, Young R. Essential Oil Safety. A Guide for Health Care Professionals. 2aed. Editorial Elsevier; 2014.
Wang GW, Hub WT, Huang BK, Qin LP. Illicium verum: A review on its botany, traditional use, chemistry and pharmacology. J Ethnopharmacol. 2011;136(1):10- 20.
Mangmeesri P, Wongsuphasawat K, Gritsanapan W, Viseshsindh W. Laxative effectiveness of cassia angustifolia in thai constipated patients. Thai J. Pharm. Sci. 2013;38(Suppl).
European Medicines Agency. Evaluation of Medicines for Human Use. Committee on Herbal Medicinal Products (HMPC). Assessment Report on Peumus Boldus Molina, Folium. London. 2009.
Ribeiro RJ, Silvestre C, Duarte C. Hidden Risks of Alternative Medicines: A Case of Boldo-Induced Hepatotoxicity. Journal of Dietary Supplements. 2016:1-5.
Ruiz A, García A, Jiménez G, Alfonso I, Pérez B, Carrazana A. Farmacovigilanica de fitofármacos y apifármacos en Cuba durante 2006-2010. Rev Cubana Plant Med. 2013. [citado 21 Agos 2016];18(2):173-186. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S102847962013000200002
Santos L, Perdomo J, González E. Comportamiento de las reacciones adversas reportadas por productos naturales. Matanzas 2003-2008. Rev Med Electrón. 2009 [citado 21 Agos 2016];31(6). Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S168418242009000600001