demonstrou que pacientes obesos que usavam a droga apresentavam um risco aumentado de problemas cardiacos e derrame.Diretores da Anvisa tiveram dois documentos para analisar: a recomendacao da Cateme e o parecer tecnico, preparado pela equipe da Anvisa. Prevaleceu o relatorio revisto da agencia. A sibutramina tera de ser vendida sob rigidas condicoes e, dentro de um ano, sera feita uma revisao sobre o impacto da manutencao do medicamento no mercado.Desde 2010, a sibutramina esta proibida na Uniao Europeia, Estados Unidos, Canada, Australia, Uruguai, Paraguai e Mexico. Toda discussao em torno de emagrecedores teve inicio depois da apresentacao dos resultados do estudo Scout. Em marco de 2010, diante das noticias de que a sibutramina aumentava o risco de problemas cardiovasculares, a Anvisa apertou o cerco para a venda do remedio e determinou que a venda do produto somente poderia ser feita com receita especial (azul). Com essa determinacao, houve queda de 32% na prescricao da sibutramina - de 2,95 milhoes de receitas para 1,99 milhao, no periodo de um ano (abril de 2010 a abril de 2011)._________________________________________________________________________________________Directors of the Agency approve the permanence of substance on the market, but there will be strict on saleBRASILIA - The National Health Surveillance Agency (ANVISA) kept the comercialization of sibutramine in Brazil and decided to ban the sale an appetite suppressant of the amphetamine derivatives. There were three votes in favor of maintaining sibutramine and one otherwise. Regarding the ban on amphetamines, the vote was unanimous.The agency said there will be time to remove the drugs from the market, sold for more than 30 years. ANVISA also intends to increase the stringency of control over the sale and use of sibutramine.decision ended a debate that has dragged on since February, when the ANVISA released a proposal to ban appetite suppressants, on the advice of the Technical Board of Medicines (CATEM) because of health risks. The announcement at the time provoked a strong reaction from medical organizations, who claimed the importance of using drugs to patients who have difficulty losing weight. Given the controversy, two public hearings were held and in the process, a reversal in the position of ANVISA.Initially in favor of the prohibition of drugs derived from amphetamine (femproporex, mazindol and amfepramone) and sibutramine, the agency could show that the matter would be resolved quickly. In February, after the first hearing and reaction of the medical profession, came the first setback: the postponement of the decision and the announcement that new public hearing would be held. In August, the second signal was given.Contrary to statements given two months before, the Head of Center of Notification ( Adverse Events),Maria Eugenia Cury, announced the review of the opinion of the technical staff. In this new version, the team kept the recommendation of the prohibition of amphetamine derivatives, but advised the permanence of sibutramine in the market, provided that certain conditions. The substance can only be sold upon presentation of a term of information, in triplicate, signed by the physician and patient. Manufacturers would still have to create a surveillance system to identify all problems related to medicine.