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Anvisa revoga recolhimento do anti 196p4v hipertensivo losartana | Folha MS
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Fachada do edifício sede da Agência Nacional de Vigilância Sanitária (Anvisa).
A Agência Nacional de Vigilância Sanitária (Anvisa) revogou medidas de recolhimento, interdição e proibição, anunciadas anteriormente, da comercialização de lotes de medicamentos que continham o princípio ativo da substância losartana, anti-hipertensivo usado para casos de insuficiência cardíaca. A resolução foi publicada no Diário Oficial da União de hoje (13).
De acordo com a Anvisa, as medidas adotadas anteriormente tinham sido tomadas de forma preventiva por questão de segurança. No entanto, “novos dados” demonstram que o consumo do medicamento é seguro, no que se refere à substância azido detectada no princípio ativo losartana.
“As evidências demonstraram, a partir de novos testes realizados, que a impureza azido não possui a toxicidade inicialmente identificada. Assim, com os novos dados apresentados, os limites de segurança foram recalculados, indicando que os lotes do medicamento que foram recolhidos ou interditados não ultraam os limites de segurança”, informou a agência.
Segundo a Anvisa, a impureza azido é uma substância que pode surgir durante o processo de fabricação do insumo farmacêutico ativo losartana. “Inicialmente, essa impureza foi considerada como de potencial mutagênico, ou seja, como possível causadora de alterações capazes de provocar danos às células humanas. Diante de estudos adicionais realizados, a impureza foi reclassificada para não mutagênica”, detalhou, por meio de nota.
Assim sendo, tendo por base resultados de estudos mais recentes, ficou demonstrado que “os produtos objeto das determinações de interdição, recolhimento e proibição estão aptos a serem mantidos no mercado. Assim, a decisão adequada foi revogar tais determinações”, acrescentou a Anvisa após informar ter recebido, da Agência de Medicina Europeia (EMA, sigla em inglês), documentos com dados científicos que dão segurança à revogação do recolhimento das medicações.
“Dessa forma, reafirma-se que os medicamentos contendo losartana são seguros e que os pacientes que fazem uso desses medicamentos devem continuar utilizando-os normalmente”, complementa a Anvisa.
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