medigraphic.com
SPANISH

Revista Cubana de Plantas Medicinales

ISSN 1028-4796 (Print)
  • Contents
  • View Archive
  • Information
    • General Information        
    • Directory
  • Publish
    • Instructions for authors        
  • medigraphic.com
    • Home
    • Journals index            
    • Register / Login
  • Mi perfil

2017, Number 1

<< Back Next >>

Rev Cubana Plant Med 2017; 22 (1)

Importance of pharmacovigilance in herbal medicine

Gruszycki KMR, Tauguinas PAL, Baez CM, Alba DDA, Gruszycki KAE
Full text How to cite this article

Language: Spanish
References: 30
Page: 1-10
PDF size: 148.86 Kb.


Key words:

pharmacovigilance, herbal medicines, adverse reactions, medicinal plants.

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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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

  10. Shaw D, Ladds G, Duez P, Williamson E, Chan K. Pharmacovigilance of herbal medicine. J Ethnopharmacol. 2012;140(3):513-8.

  11. 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.

  12. 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.

  13. 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

  14. 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

  15. The Uppsala Monitoring Centre. Guidelines for Herbal ATC Classification. Uppsala, Sweden. WHO Colaborating Centre for International Drug Monitoring. 2004.

  16. WHO International monitoring of adverse reactions to drugs: adverse reaction terminology. WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden. 1992.

  17. 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

  18. Woolf AD. Herbal Remedies and Children: Do They Work? Are They Harmful? Pediatrics. 2003;112(1 Pt 2):240-6.

  19. 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

  20. Lorenzo P, Moreno A, Lizasoain I, Leza JC, Moro MA, Portolés A. Velázquez Farmacología Básica y Clínica. 18 aed. Madrid. Editorial Médica Panamericana. 2010.

  21. Scarpa G. Medicinal plants used by the Criollos of Northwestern Argentine Chaco. J Ethnopharmacol. 2004;91(1):115-35.

  22. 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

  23. Alonso J. Tratado de Fitofármacos y Nutracéuticos. 1aed. Buenos Aires, Argentina. Editorial Corpus; 2008.

  24. Tisserand R, Young R. Essential Oil Safety. A Guide for Health Care Professionals. 2aed. Editorial Elsevier; 2014.

  25. 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.

  26. Mangmeesri P, Wongsuphasawat K, Gritsanapan W, Viseshsindh W. Laxative effectiveness of cassia angustifolia in thai constipated patients. Thai J. Pharm. Sci. 2013;38(Suppl).

  27. European Medicines Agency. Evaluation of Medicines for Human Use. Committee on Herbal Medicinal Products (HMPC). Assessment Report on Peumus Boldus Molina, Folium. London. 2009.

  28. Ribeiro RJ, Silvestre C, Duarte C. Hidden Risks of Alternative Medicines: A Case of Boldo-Induced Hepatotoxicity. Journal of Dietary Supplements. 2016:1-5.

  29. 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

  30. 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




2020     |     www.medigraphic.com

Mi perfil

C?MO CITAR (Vancouver)

Rev Cubana Plant Med. 2017;22