Foto: Reprodução
A Agência Nacional de Vigilância Sanitária (Anvisa) determinou nesta quinta feira (23) a interdição e recolhimento de lotes dos medicamentos com princípio ativo da Losartana. Segundo a Anvisa, “a medida foi tomada devido a presença da impureza “azido” em concentração acima do limite de segurança aceitável”.
A Agência já havia dado publicidade aos recolhimentos voluntários anteriores, realizados pelas próprias empresas farmacêuticos nos meses de setembro e outubro de 2021 e junho de 2022.
As impurezas chamadas de “azido” são substâncias que podem surgir durante o processo de fabricação do insumo farmacêutico ativo e que tem potencial mutagênico. Impurezas mutagênicas são substâncias químicas que podem causar mudanças no DNA de uma célula. A medida é preventiva e foi tomada após a realização de análises nos produtos do mercado brasileiro. As avaliações foram realizadas pelos fabricantes do medicamento no Brasil por determinação da Anvisa.
Este tipo de medicação é um dos mais indicados e usados no Brasil para o tratamento de pressão alta (hipertensão arterial) e insuficiência cardíaca, reduzindo o risco de derrame e infarto. Mas a agência enfatiza que as pessoas que utilizam o medicamento não devem interromper o seu tratamento, pois pode levar a problemas graves. Ainda segundo a Anvisa “a medida é preventiva e foi tomada após a evolução do conhecimento sobre as impurezas e para adequar os produtos utilizados no Brasil aos limites técnicos previstos para a presença do contaminante nos medicamentos.”
A lista que foi divulgada de produtos afetados inclui lotes que deverão ser recolhidos pelas empresas e outros que ficarão interditados até que seja concluída as análises sobre a presença do contaminante nos medicamentos.
A Agência esclarece que os lotes que foram mantidos no mercado são considerados seguros e podem ser consumidos.
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