Farmacovigilância: um passo em direção ao uso racional de plantas medicinais e fitoterápicos

Abstract

RESUMO:Neste artigo são apresentados os resultados da avaliação das notificações de eventos adversos a plantas medicinais e seus derivados (fitoterápicos), efetuadas voluntariamente ao Sistema Nacional de Farmacovigilância, coordenado pela Agência Nacional de Vigilância Sanitária, no período de janeiro de 1999 a março de 2009. A farmacovigilância envolve a detecção de reações adversas que ocorrem durante ou após o uso de um medicamento, a interação medicamentosa, o desvio de qualidade, o uso abusivo e a inefetividade. Como as pesquisas realizadas para a avaliação do uso eficaz e seguro de fitoterápicos são incipientes, as notificações de eventos auxiliam na geração de novas informações, promovendo seu uso racional.Unitermos: Fitoterápicos, plantas medicinais, farmacovigilância, evento adverso, Anvisa.ABSTRACT: "Pharmacovigilance: a step towards the rational use of herbs and herbal medicines". This article presents the evaluation of the notifications of adverse events related to medicinal plants and their derivatives (herbal medicines). Such evaluations were voluntarily run by the Brazilian Pharmacovigilance System, coordinated by the Brazilian Health Surveillance Agency (Anvisa), from January 1999 to March 2009. Pharmacovigilance involves the detection of adverse reactions that occur during or after the use of drugs, drug interactions, problems of quality, improper use and inefficacy. There is scarce scientific confirmation about efficacy and safety of herbal medicines, so the notification of adverse events provides of information, and promotes rational use.

Pesquisa e atividades de extensão em fitoterapia desenvolvidas pela Rede FitoCerrado: uso racional de plantas medicinais e fitoterápicos por idosos em Uberlândia-MG

“…A identificação errônea das espécies vegetais, forma de preparo incorreta e o uso indiscriminado podem ser perigosos, levando a superdosagem, ineficácia terapêutica e efeitos indesejáveis, o que pode acarretar sérios danos ao usuário com o comprometimento da recuperação de sua saúde (Balbino & Dias, 2010;WHO, 2004).…”

Are medicinal herbs safe? The opinion of plant vendors from Diadema (São Paulo, southeastern Brazil)

“…Many of these herbs are believed to be free of risks and are commonly used for self-medication without supervision. During the last three decades, there has been the most remarkable revival of herbal medicine (Balbino & Dias, 2010). A further strength of herbal medicines is that they are inexpensive, or at least, cheaper than conventional remedies.…”

“…Furthermore, interactions with traditional drugs are possible, leading to a lower effi cacy of pharmacological treatments or to toxic manifestations (Cuzzolin et al, 2006). In recent years, adverse events possibly associated with a wide range of herbal remedies have been published elsewhere (Ries & Sahud, 1975;Arseculeratne et al, 1985;Stickel et al, 2005;Sossai et al, 2007;Balbino & Dias, 2010).…”

Development of Instrument to Report and Assess Causality of Adverse Events Related to Herbal Medicines

“…In Brazil, after development of electronic reporting of adverse events (NOTIVISA), in 2008, no reports of problems related to the use of herbal medicines was received by the National Surveillance Agency (ANVISA) [8] . Our findings suggest the form develop is an appropriate instrument to report adverse events arising from herbal medicines.…”

“…Herbal medicines are associated with the development of serious adverse reactions [8][9][10] , which may cause life-threatening [9] , hospital admissions [11] , and death [8,9,12] . In addition, other factors may increase the risk of occurrence of adverse events, such as tampering, poor quality, lack of proper identification, contamination and inappropriate use [13] as well as improper storage and handling [14] and packaging [15] .…”