ABSTRACT
Thalidomide is the best-known teratogen worldwide. It was first marketed as a sedative in the late 1950s, but the birth of ~10 000 children with birth defects resulted in the withdrawal of thalidomide from the market in 1962. Thalidomide embryopathy affects almost all organs but the main defects are concentrated in the limbs, eyes, ears, and heart. Shortly after the withdrawal of thalidomide from the market, its effectiveness in the treatment of erythema nodosum leprosum, an inflammatory condition resulting from leprosy, was reported and since the mid-1990s, the drug has been used widely in the treatment of cancers and autoimmune diseases, among other conditions. 40 000 new cases of leprosy are diagnosed every year in Brazil. Although there is a strict legislation for the prescription and use of thalidomide in Brazil, cases of thalidomide embryopathy have continued to be reported. Here, we present two new cases of thalidomide embryopathy identified in 2011 and review the major clinical findings in the literature that can aid the identification of the embryopathy.
Subject(s)
Fetal Diseases/chemically induced , Leprosy/epidemiology , Thalidomide/adverse effects , Brazil/epidemiology , Endemic Diseases , Erythema Nodosum/drug therapy , Female , Humans , Hypnotics and Sedatives/adverse effects , Legislation, Drug , Leprosy/drug therapy , Leprosy/pathology , Male , Polydactyly/chemically inducedABSTRACT
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.
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.