Use of Domperidone as a Galactagogue Drug: A Systematic Review of the Benefit-Risk Ratio
Most women can make all the milk their baby needs, but some mothers turn to medications to help increase their supply. While some specialists encourage the off-label use of domperidone to stimulate breast milk production, some studies have suggested it may be related to negative side effects, including irregular heartbeat and sudden cardiac death. In this article researchers concluded that although domperidone can increase breast milk production, and there is no known risk to the babies who drink the milk, risks to women are still worrying. As some women are highly susceptible to certain heart diseases, the researchers claimed the use of domperidone was especially worrisome: “In these circumstances, an improvement of breastfeeding practices seems to be more effective and safer than the use of an off-label domperidone treatment.”
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.
Catherine Paul, Marie Zénut, Agnès Dorut, Marie-Ange Coudoré, Julie Vein, Jean-Michel Cardot, and David Balayssac
Use of Domperidone as a Galactagogue Drug: A Systematic Review of the Benefit-Risk Ratio J Hum Lact 0890334414561265, first published on December 4, 2014 doi:10.1177/0890334414561265