Module232025

07/05/2025

Lactation

The Organisation for Professionals in Regulatory Affairs

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Do the benefits of breast-feeding outweigh the risk of potential infant drug exposure?

Lactating women form a category of therapeutic orphans: Of 422 NCE approvals between 2001 and 2020, only 23 included human lactation data 11 Lactation studies considered appropriate when: drug under review likely to be used by WOCBP use by WOCBP becomes apparent new indication indicates likely use by WOCBP Evidence quantitatively describing drug transfer through breastmilk and informing the clinical risk- to-benefit ratio seldom exists concerns about clinical trials in pregnancy and the resultant foetal drug exposure 8 infant exposure through breast milk is typically lower than that which occurs through placental transfer during pregnancy, 9 but exceptions do exist 10

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