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Possuem Impurezas

Anvisa decide proibir venda e recolher vários lotes de remédios à base de losartana

Da Redação*
Publicado em 23/06/2022 às 17:57.Atualizado em 23/06/2022 às 18:01.

A Agência Nacional de Vigilância Sanitária (Anvisa) determinou, nesta quinta-feira (23), a proibição de venda e recolhimento de lotes de medicamentos para hipertensão contendo losartana. Segundo a Anvisa, a medida foi tomada devido à presença acima do permitido da impureza chamada “azido”.

A losartana é o anti-hipertensivo e um dos medicamentos para insuficiência cardíaca mais utilizados no Brasil, informou a agência.

Apesar da decisão, os pacientes que utilizam o medicamento não devem interromper o tratamento, mesmo que estejam usando algum lote afetado pela medida desta quinta. A suspensão indevida do uso pode causar danos graves à saúde.

“A medida preventiva foi adotada após  a evolução do conhecimento sobre as impurezas e serve para adequar os produtos utilizados no Brasil aos limites técnicos previstos para a presença desse contaminante”, disse a Anvisa em seu site.

A lista de remédios que devem ser recolhidos do mercado consta deste link e os medicamentos interditados, neste outro endereço.

A Vigilância Sanitária dá as seguintes recomendações a quem possuir caixa de losartana que faz parte da proibição:

  • Continue o tratamento
  • Converse com o médico em caso de dúvida ou necessidade de orientação
  • Entre em contato com o Serviço de Atendimento ao Consumidor (consultar a bula) do laboratório para se informar sobre a troca do medicamento por um lote que não tenha sido afetado pelo recolhimento ou interdição
  • Há no mercado outras losartanas que podem substituir os medicamentos recolhidos ou interditados
  • Somente troque de medicamento quando já tiver o novo em mãos, pois a interrupção do tratamento da hipertensão arterial e da insuficiência cardíaca pode produzir malefícios instantâneos, inclusive risco de morte por derrame, ataques cardíacos e  piora da insuficiência cardíaca
  • Não há risco imediato em relação ao uso dessa medicação, porque não existem dados que indiquem um aumento dos eventos adversos
  • Os medicamentos contendo “sartanas” são seguros e eficazes no controle do tratamento de hipertensão e insuficiência cardíaca, reduzindo significativamente o risco de derrame e infarto

O que são as impurezas azido?
De acordo com a Anvisa, as impurezas azido são substâncias que podem surgir durante o processo de fabricação do insumo farmacêutico ativo e possuem potencial mutagênico.

A decisão desta quinta (23) é preventiva, e foi adotada após as descobertas das impurezas e realização de análises dos produtos disponíveis no mercado brasileiro, conforme a agência.

A descoberta da possibilidade de presença do azido na losartana se deu, originalmente, em setembro de 2021.

A Anvisa notificou os detentores de registro dos medicamentos para apresentarem os resultados da avaliação acerca da existência dessa impureza em seus produtos. Outras autoridades reguladoras no mundo também adotaram ações de recolhimento, como na Alemanha, Austrália, Canadá, Estados Unidos da América, Portugal, República Tcheca e Singapura.

(*) Com site da Anvisa

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