Uma intercorrência frequente na gravidez, a êmese/hiperêmese gravídica, é preocupação permanente e atual de todos os obstetras e pesquisadores que atuam na saúde da gestante, muito se avançou no seu tratamento, mas ainda não é suficiente.
Nos últimos anos observou-se uma superioridade do efeito antiemético entre as usuárias de Ondansetrona e com baixos efeitos colaterais quando comparados aos outros antieméticos, o que fez rapidamente tornar a ondansetrona o medicamento mais frequente prescrito para náuseas e vômitos durante a gravidez no mundo.
No entanto, no dia 12 de setembro de 2019, a Agência Espanhola de Medicamentos e Produtos Sanitários (AEMPS) publicou uma nota informativa proibindo o uso de ondansetrona durante a gravidez, pelo risco aumentado de defeitos de fechamento orofacial e malformações cardíacas, especialmente no primeiro trimestre. Recomendando ainda que as mulheres em idade fértil em uso desse medicamento sejam informadas dos riscos e que utilizem medidas contraceptivas seguras.
Essa nota da AEMPS foi baseada em dois estudos retrospectivos recentes conflitantes e controversos. O primeiro encontrou que o uso da ondansetrona no primeiro trimestre está associado com um pequeno risco de fendas orais, principalmente fenda palatina, mas não com defeitos cardíacos. O segundo estudo mostrou um aumento de defeitos cardíacos, mas não de defeitos de fendas orais. No estudo que apresentou aumento absoluto do risco de fissura orofacial e/ou palatina, esse aumento foi muito pequeno, afetando aproximadamente 14 por 10.000 nascimentos, em comparação com uma taxa de 11 por 10.000 dos recém-nascidos não expostos. Isso equivale a três casos adicionais de fenda orofacial por 10.000 gestantes que usam ondansetrona durante o primeiro trimestre. Esse mesmo estudo concluiu que quando os resultados são ajustados para um grande número de variáveis relevantes, não se encontra aumento de malformações no grupo daquelas que usaram a Ondansetrona.
A FEBRASGO, enquanto não houver outras evidências, orienta prudência com divulgação desses resultados e não ve motivo para o não uso da Ondansetrona na gravidez, prestando esclarecimento para gestantes sobre o baixo risco de malformações, deixando seu uso, preferencialmente, quando medidas de apoio e dietéticas associadas a outros fármacos não mostrarem sucesso.
São Paulo, 04 de outubro de 2019.
Comissão Nacional Especializada de Assistência Pré-Natal da Febrasgo
Diretoria da Febrasgo
REFERÊNCIAS
- Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).:2. 3 Ondansetrón: riesgo de defectos de cierre orofacialies (lábio leporino, paladar hendido) tras uso durante el primer trimestre del embarazo. Ministerio de Sanida, Consumo y Bienestar Social. Nota informativa, 2019.
- Huybrechts KF et al. Association of Maternal First-Trimester Ondansetron Use With Cardiac Malformations and Oral Clefts in Offspring. JAMA. 2018 Dec 18; 320 (23): 2429-2437.
- Zambelli-Weiner A et al. First Trimester Ondansetron Exposure and Risk of Structural Birth Defects. Reprod Toxicol. 2019 Jan; 83: 14–20
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