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).
Segundo 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 ultrapassam os limites de segurança”, informou a agência.
Para a Agência, 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.
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