Controle de N-nitrosaminas: uma perspectiva regulatória
Arquivos
Data
2023-11-30
Autores
Ramos, Thayna Silveira Pestana de Souza 
Orientadores
Calixto, Leandro Augusto
Tipo
Trabalho de conclusão de curso
Título da Revista
ISSN da Revista
Título de Volume
Resumo
As N-nitrosaminas compreendem uma classe de impurezas encontradas em medicamentos e,
muitas delas são consideradas agentes mutagênicos e/ou carcinogênicos em potencial. O
controle de tais impurezas em medicamentos é de fundamental importância para a garantia de
qualidade, segurança e eficácia dos produtos comercializados. Já é demonstrado que a
exposição de pacientes à N-nitrosaminas pode acarretar efeitos irreversíveis a longo prazo,
devido a seu elevado potencial de induzir tumores em diferentes órgãos. Apesar de serem
conhecidas desde o século XX, foi apenas em 2018 que sua presença em medicamentos se
tornou um alerta para autoridades de saúde. Desde então, novas pesquisas vêm sendo realizadas
e novos estudos publicados, comprovando o potencial risco que sempre esteve presente na
rotina de pacientes. O presente trabalho teve como objetivo apresentar a percepção das agências
reguladoras e da área de assuntos regulatórios sobre o controle de N-nitrosaminas, a partir da
apresentação dos recolhimentos realizados, das formas de contaminação e das dificuldades
envolvidas na elaboração de análises de risco pelas indústrias farmacêuticas, considerando as
diretrizes estabelecidas por autoridades de saúde. Pode-se concluir que o aprimoramento do
conhecimento relacionado a N-nitrosaminas pelas indústrias farmacêuticas é essencial na
garantia da segurança dos medicamentos. Esse progresso está intrinsecamente ligado ao
desenvolvimento contínuo de tecnologias analíticas mais sensíveis e à implementação de
estratégias de mitigação de riscos eficazes. Espera-se que o conhecimento químico relativo a
esta classe de impurezas continue a expandir ao longo dos próximos anos, visando garantir um
uso cada vez mais seguro dos medicamentos pelos pacientes.
NNitrosamines include a class of impurities found in drug products, and many of them are considered potential mutagens and/or carcinogens. The control of such impurities in drugs is fundamentally important for guaranteeing the quality, safety and efficacy of marketed drugs. It has already been demonstrated that the exposure of patients to NNitrosamines can lead to irreversible longterm effects, due to their high potential to induce tumors in different organs. Although they have been known since the 20th century, it was only in 2018 that their presence in drugs became a warning for health authorities. Since then, new research has been carried out and new studies published, demonstrating the potential risk that has always been present in the routine of patients. The purpose of this document was to present the perspective of regulatory agencies and the area of regulatory affairs on the control of Nnitrosamines, by presenting the recalls carried out, the sources of contamination and the difficulties involved in the preparation of risk assessments by the pharmaceutical companies, taking into account the guidelines established by health authorities. It can be concluded that the improvement of knowledge related to Nnitrosamines by pharmaceutical industries is crucial in guaranteeing drug safety. This progress is intrinsically linked to the continuous development of more sensitive analytical technologies and the implementation of effective risk mitigation strategies. It is expected that chemical knowledge relating to this class of impurities will continue to expand over the next years, in order to guarantee an even safer use of drugs by patients.
NNitrosamines include a class of impurities found in drug products, and many of them are considered potential mutagens and/or carcinogens. The control of such impurities in drugs is fundamentally important for guaranteeing the quality, safety and efficacy of marketed drugs. It has already been demonstrated that the exposure of patients to NNitrosamines can lead to irreversible longterm effects, due to their high potential to induce tumors in different organs. Although they have been known since the 20th century, it was only in 2018 that their presence in drugs became a warning for health authorities. Since then, new research has been carried out and new studies published, demonstrating the potential risk that has always been present in the routine of patients. The purpose of this document was to present the perspective of regulatory agencies and the area of regulatory affairs on the control of Nnitrosamines, by presenting the recalls carried out, the sources of contamination and the difficulties involved in the preparation of risk assessments by the pharmaceutical companies, taking into account the guidelines established by health authorities. It can be concluded that the improvement of knowledge related to Nnitrosamines by pharmaceutical industries is crucial in guaranteeing drug safety. This progress is intrinsically linked to the continuous development of more sensitive analytical technologies and the implementation of effective risk mitigation strategies. It is expected that chemical knowledge relating to this class of impurities will continue to expand over the next years, in order to guarantee an even safer use of drugs by patients.