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Anvisa atualiza bula da vacina de Oxford/Astrazeneca

23 de março de 2021 Redação

Duas reações adversas foram incluídas na bula da vacina contra a covid-19 Oxford/Astrazeneca/Fiocruz. A primeira é uma reação que pode ser comum, a diarreia. A segunda reação, considerada uma reação incomum após a administração da vacina, é a sonolência. A informação foi divulgada nesta terça-feira (23) pela Agência Nacional de Vigilância Sanitária (Anvisa). Segundo a agência, as alterações na bula foram realizadas no dia 16 de março, após análise da área de farmacovigilância.

Mudança

A inclusão das duas reações identificadas nos estudos clínicos e em bulas do produto em outros países foi solicitada pela Anvisa, por ocasião da análise do Plano de Gerenciamento de Riscos, durante a etapa de registro da vacina de Oxford/AstraZeneca/Fiocruz.

“O plano de gerenciamento de riscos é uma das etapas para o registro dos medicamentos e vacinas no Brasil. Nenhum produto é isento de riscos e por isso devem ser monitorados. Ele é registrado quando os benefícios superam os riscos, mas essa relação deve ser constantemente avaliada”, explicou a Anvisa em nota.

Uma vez no mercado é iniciada a etapa de monitoramento dos riscos das vacinas ou farmacovigilância. Nessa etapa são avaliadas informações de notificações e da análise de causalidade dos casos suspeitos relatados, sumários executivos de eventos adversos, relatórios periódicos de análise de benefício-risco e de gerenciamento de sinais de segurança. Também são feitas consultas a especialistas, além do constante intercâmbio de informações com autoridades regulatórias de outros países e com a Organização Mundial da Saúde (OMS).

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