title: Use of domperidone as a galactagogue drug: a systematic review of the benefit-risk ratio.
abstract: Breastfeeding is the optimal method for feeding a newborn. However, some mothers may have difficulties lactating. Domperidone is widely used as a galactagogue but to the best of our knowledge has not been approved by any health authority. The objective of this review was to assess the benefit-risk ratio of domperidone for stimulating lactation. The benefit-risk ratio of domperidone as a galactagogue was assessed following a literature search of the PubMed database up to July 2013. Four studies were selected to assess domperidone efficacy and demonstrated an increased milk production. The limited data (60 mother-baby pairs) and the moderate methodological quality of 1 study remain insufficient to conclude on domperidone efficacy. Regarding the safety of domperidone, 7 studies were selected that exposed 113 infants to domperidone through breastfeeding. No adverse effects were observed in 85 infants, and no information was provided for the remaining 28. The limited data available remain in favor of a safe domperidone profile in infants and mothers. However, in large studies focused on gastrointestinal disorders, domperidone is responsible for drug-induced long QT syndrome and sudden cardiac death. The use of domperidone as a galactagogue is worrisome as drug-induced long QT syndrome occurred mostly in women. In these circumstances, an improvement of breastfeeding practices seems to be more effective and safer than the use of an off-label domperidone treatment.
authors.affiliation: Université d'Auvergne, Faculté de Pharmacie, Clermont-Ferrand, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Paul
authors.affiliation: CHU Clermont-Ferrand, Centre Regional de Pharmacovigilance, Clermont-Ferrand, France EA 4681 PEPRADE, Université d'Auvergne, Clermont-Ferrand, France.
authors.forename: Marie
authors.initials: M
authors.lastname: Zénut
authors.affiliation: CHU Clermont-Ferrand, Service d'Obstétrique, Clermont-Ferrand, France.
authors.forename: Agnès
authors.initials: A
authors.lastname: Dorut
authors.affiliation: Université d'Auvergne, Faculté de Pharmacie, Laboratoire de Physiologie, Clermont-Ferrand, France CHU Clermont-Ferrand, Hématologie Biologique, Clermont-Ferrand, France.
authors.forename: Marie-Ange
authors.initials: MA
authors.lastname: Coudoré
authors.affiliation: INSERM U1107, NEURO-DOL, Université d'Auvergne, Clermont-Ferrand, France.
authors.forename: Julie
authors.initials: J
authors.lastname: Vein
authors.affiliation: Université d'Auvergne, Faculté de Pharmacie, Laboratoire de Biopharmacie, Clermont-Ferrand, France CHU Clermont-Ferrand, INSERM CIC 1405, Centre de Pharmacologie Clinique, Clermont-Ferrand, France.
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Cardot
authors.affiliation: INSERM U1107, NEURO-DOL, Université d'Auvergne, Clermont-Ferrand, France CHU Clermont-Ferrand, Délégation à la Recherche Clinique et à l'Innovation, Clermont-Ferrand, France dbalayssac@chu-clermontferrand.fr.
authors.forename: David
authors.initials: D
authors.lastname: Balayssac
mesh_terms: D001942:Breast Feeding; D004294:Domperidone / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D056669:Galactogogues / Q000009:adverse effects / Q000494:pharmacology*; D006801:Humans; D007231:Infant, Newborn; D008895:Milk, Human / Q000187:drug effects*; D018570:Risk Assessment
chemical_list: D056669:Galactogogues; D004294:Domperidone
keywords: benefit-risk ratio; breastfeeding; domperidone