The new FDA rules for pregnancy and lactation labeling

• Autor(a) principal: Rocha, Renan
• Data de Publicação: 2015
• Outros Autores: Rennó Jr., Joel, Ribeiro, Hewdy Lobo, Cavalsan, Juliana Pires, Cantilino, Amaury, Ribeiro, Jerônimo De Almeida Mendes, Valadares, Gislene, Silva, Antônio Geraldo da
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Debates em Psiquiatria (Online)
• Texto Completo: https://revistardp.org.br/revista/article/view/159
• topic: Bula; medicamento; gravidez; lactação; Labeling; drug; pregnancy; lactation

New rules set forth by the Food and Drug Administration (FDA) for the use of drugs during pregnancy and lactation take effect this year (2015). They reshape the content and format of labeling and concomitantly remove any reference to the A, B, C, D, and X categories. The latter are replaced by a summary of the perinatal risks associated with the drug, discussion of related evidence, and a summary of the most relevant data for prescription decision-making. Also, the new rules include essential information on the identificati on of pregnancy, contraception, and infertility. The ultimate goal of the new rules is to facilitate the process of prescribing drugs by offering consistent, well-structuredinformation about the use of drugs during pregnancy and lactation.