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Use of Domperidone As a Galactagogue Drug: a Systematic

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Use of Domperidone As a Galactagogue Drug: a Systematic JHLXXX10.1177/0890334414561265Journal of Human LactationPaul et al 561265research-article2014 Review Journal of Human Lactation 2015, Vol. 31(1) 57 –63 Use of Domperidone as a Galactagogue © The Author(s) 2014 Reprints and permissions: sagepub.com/journalsPermissions.nav Drug: A Systematic Review of the DOI: 10.1177/0890334414561265 Benefit-Risk Ratio jhl.sagepub.com Catherine Paul, PharmD1, Marie Zénut, MD, PhD2,3, Agnès Dorut, CPM4, Marie-Ange Coudoré, PharmD, PhD5,6, Julie Vein, DVM, PhD7, Jean-Michel Cardot, PharmD, PhD8,9, and David Balayssac, PharmD, PhD7,10 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. Keywords benefit-risk ratio, breastfeeding, domperidone Background 1Université d’Auvergne, Faculté de Pharmacie, Clermont-Ferrand, France Mothers who delivered preterm infants often have difficul- 2CHU Clermont-Ferrand, Centre Regional de Pharmacovigilance, 1 Clermont-Ferrand, France ties producing sufficient amounts of milk. Additionally, 3 mothers of term infants can have, under certain circum- EA 4681 PEPRADE, Université d'Auvergne, Clermont-Ferrand, France 4CHU Clermont-Ferrand, Service d’Obstétrique, Clermont-Ferrand, France stances, difficulties with producing enough milk for their 5Université d’Auvergne, Faculté de Pharmacie, Laboratoire de Physiologie, infants (eg, maternal illness, cesarean delivery, maternal Clermont-Ferrand, France smoking, previous breast surgery, mother-infant separation, 6CHU Clermont-Ferrand, Hématologie Biologique, Clermont-Ferrand, France 7 and psychosomatic disorders).2,3 Women and clinicians often INSERM U1107, NEURO-DOL, Université d’Auvergne, Clermont- Ferrand, France turn to galactogogue drugs or supplements to try and increase 8 3 Université d’Auvergne, Faculté de Pharmacie, Laboratoire de supply. The use of dopamine receptor antagonists, such as Biopharmacie, Clermont-Ferrand, France metoclopramide or domperidone, is probably the most wide- 9CHU Clermont-Ferrand, INSERM CIC 1405, Centre de Pharmacologie spread pharmacological strategy.4 Clinique, Clermont-Ferrand, France 10 Domperidone is a prokinetic and antiemetic drug for the CHU Clermont-Ferrand, Délégation à la Recherche Clinique et à treatment of gastroparesis, nausea, and vomiting, approved l’Innovation, Clermont-Ferrand, France worldwide with the exception of the US (mainly due to car- FastTrack papers are considered high impact. After peer review, we diotoxicity).5,6 Antiemetic activity results from the associa- speed up their publication so JHL readers can access important new tion of peripheral effects on gastric motility and dopaminergic information as soon as possible. FastTrack papers may not always be related to themed content in special issues. antagonism of the chemoreceptors in the trigger zone, which 7 is outside the blood brain barrier in the area postrema. Date submitted: April 29, 2014; Date accepted: November 3, 2014. Domperidone has a strong affinity for dopaminergic D2 receptors in the peripheral nervous system and the gastroin- Corresponding Author: testinal system.7 Despite its antidopaminergic effect, dom- David Balayssac, PharmD, PhD, INSERM U1107, NEURO-DOL, Laboratoire de Toxicologie, Faculté de Pharmacie, 28 place Henri Dunant, peridone is rarely responsible for extrapyramidal side 63000 Clermont-Ferrand, France. 8 effects because it hardly crosses the blood brain barrier. Email: [email protected] Downloaded from jhl.sagepub.com at MCGILL UNIVERSITY LIBRARY on November 24, 2015 58 Journal of Human Lactation 31(1) Domperidone is rapidly absorbed after oral intake, with a For the assessment of domperidone efficacy and maternal peak plasma concentration between 30 and 60 minutes. safety, only the publications measuring the production of However, the oral bioavailability is low (15%) due to milk in lactating women and comparing a domperidone hepatic first pass metabolism. Food intake delays the peak treated group to a control group were selected for the review. plasma concentration but increases the bioavailability. For the assessment of domperidone safety in infants, publi- Domperidone binds strongly to plasma protein (91%-93%) cations were selected if the infants were exposed to domperi- and is widely distributed in tissues, with the exception of done through breastfeeding. the central nervous system. After oral administration, dom- peridone is rapidly and intensively metabolized by hydrox- Results ylation and N-dealkylation by CYP3A enzymes in the gut wall and the liver.9 Two-thirds of the administrated dose Bibliographic Results are eliminated in feces and the remaining third in urine, The literature search collected 89 references, and the mainly as metabolites (90%). Plasma half-life after oral selection of the references for the review is presented in intake is about 7 to 9 hours and increases in cases of renal 8 the Figure 1. Two meta-analyses assessing domperidone failure. efficacy as a galactagogue have been identified and The use of domperidone as a galactagogue was first 14,15 10 selected. Seven clinical studies focusing on domperi- described in 1983. This property results from its antidopa- done and lactation have been identified.12,13,16-20 Among the minergic effect on D2 receptors of the lactotropic cells of remaining 7 publications, 4 studies fulfilled the inclusion the anterior pituitary gland, bearing in mind that dopamine 12,18-20 13,16,17 11 criteria of domperidone efficacy, and 3 studies is the main inhibitor of prolactin release. In a randomized were excluded due to methodological bias (absence of con- clinical trial, the prolactinemia of treated women (n = 24) trol groups or irrelevant comparator). The domperidone increased by 302% compared to 85% in control women (n = safety in infants was assessed from the 7 publications cor- 21) (P = .03) after 4 days of domperidone treatment (10 mg, responding to infants exposed to domperidone through 3 times a day). After 14 days of domperidone treatment, the 12,13,16-20 breastfeeding. increase of the prolactinemia was only 107% in treated women compared to 17% in control women (P = .07).12 Galactorrhea following domperidone treatment remains, Domperidone Efficacy as a Galactagogue however, a rare adverse drug reaction (frequency: > 1/10 All 4 studies selected from the literature search were con- 8 000 and < 1/1000). trolled double-blind studies,12,18-20 and 3 studies12,18,20 were To the best of our knowledge, the use of domperidone as randomized (Table 1). Women were included due to an inad- 13 a galactagogue has not been approved by any authority. equate postpartum milk production12,18,19 or after a cesarean Consequently, an adequate assessment of the benefit-risk birth.20 All definitions of lactation insufficiency were ratio of domperidone is essential before prescribing this accepted, the most frequent definition being a milk produc- drug for lactation failure. The objective of this systematic tion insufficient for the daily needs of the infant. All the review of the literature was to conduct an assessment of the mothers who delivered vaginally were included a few weeks benefit-risk ratio of domperidone use as a galactagogue, after the delivery, leaving a sufficient period necessary for with regards to milk production, excretion of domperidone the initiation of lactation, with lactation support if required. in milk, quality of milk, and safety of the mothers and However, only 1 study19 mentioned that advice on improv- infants during domperidone treatment. ing lactation had been given before inclusion into the trial. For the mothers who delivered by cesarean section, the Methods domperidone treatment was initiated as soon as they were able to take liquid beverages, namely, 24 hours after the A single author performed a literature search of the PubMed delivery. In these 3 studies, the doses of domperidone were database (up to July 2013) in order to assess the benefit-risk approximately 30 to 40 mg/day (10 mg, 3-4 times per os). A ratio of domperidone. The search used the keywords dom- double-blind procedure was used for the administration of peridone associated with lactation, galactagogue, milk, or
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