FDA Warns Against Breast Milk Drug

First‐in‐Human Study of Merotocin, a Short‐Acting Peptidic Oxytocin Receptor Agonist for Lactation Support

“…[8][9][10][11] Centrally-acting agents have important safety concerns that prompted regulatory authorities to issue warnings or restrict their use, and herbal galactagogues lack data on safety and efficacy. [11][12][13] Oxytocin plays a central role in lactation, including milk synthesis, secretion, and ejection, and is approved as a nasal spray for lactation support in only a few European countries. A placebo-controlled study of high-dose nasal oxytocin in mothers expressing milk for preterm infants showed an effect 14 that could not be verified at a slightly lower dose.…”

“…First‐line treatment is usually education and support of optimal lactation behaviors (eg, expression frequency, duration, and method) 7 ; however, if inadequate milk supply persists, therapies such as herbal galactagogues (eg, moringa, milk thistle, and fenugreek) or off‐label use of dopamine antagonists such as domperidone and metoclopramide have been used to promote milk production 8–11 . Centrally‐acting agents have important safety concerns that prompted regulatory authorities to issue warnings or restrict their use, and herbal galactagogues lack data on safety and efficacy 11–13 …”

“… 8 , 9 , 10 , 11 Centrally‐acting agents have important safety concerns that prompted regulatory authorities to issue warnings or restrict their use, and herbal galactagogues lack data on safety and efficacy. 11 , 12 , 13 …”

A Critical Review of Pharmaceutical Galactagogues

“…64,65 The FDA has warned against the use of domperidone as a galactagogue because no FDAapproved products are marketed and because cardiac arrhythmia, cardiac arrest, and death reported after intravenous administration of domperidone. 66,67 Since maternal serum levels of domperidone are much higher after intravenous than oral use, the relevance of these deaths to the use of oral domperidone as a galactagogue has been questioned. 68 However, domperidone can prolong the QT interval, particularly in the presence of potent CYP3A4 inhibitors such as ketoconazole (now listed as a contraindication to domperidone therapy by the manufacturer), erythromycin, and grapefruit juice, which can markedly increase systemic domperidone exposure.…”