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Motherisk Update
Health Canada advisory on domperidone

Should I avoid prescribing domperidone to women to increase milk production? Pina Bozzo Gideon Koren MD FRCPC FACMT Shinya Ito MD FRCPC
Abstract
Question
I often prescribe domperidone to women as a galactagogue starting at a dose of 30 mg and increasing
the dose as needed. In March of this year, Health Canada released an advisory warning of domperidone use and
abnormal heart rhythms and sudden cardiac death. Should I cap doses at 30 mg or stop prescribing domperidone all
together to these women?
Answer The Health Canada warning is based on 2 studies. The results of the studies are not directly applicable to
breastfeeding and should not change the way you normally manage otherwise healthy breastfeeding women. Avis de Santé Canada sur la dompéridone
Devrais-je éviter de prescrire de la dompéridone aux femmes pour augmenter la production de lait? Résumé
Question
Je prescris souvent de la dompéridone aux femmes comme galactagogue, en commençant par une dose
de 30 mg et en augmentant cette dose au besoin. En mars cette année, Santé Canada a publié une mise en garde
concernant l’utilisation de la dompéridone et les risques d’anomalies graves du rythme cardiaque et de mort subite.
Devrais-je limiter les doses à 30 mg ou arrêter complètement de prescrire de la dompéridone à ces femmes?
Réponse  L’avis de Santé Canada se fonde sur 2 études. Les résultats de ces études ne sont pas directement
applicables à l’allaitement maternel et ne devraient pas changer la façon dont vous prenez normalement en charge
les femmes autrement en bonne santé qui allaitent.
Domperidone is a dopamine antagonist with anti- infants). Only minimal amounts of domperidone are
emetic and gastroprokinetic properties.1 It is indi- excreted into breast milk (less than 0.1% of the mater- cated for the symptomatic management of upper nal weight-adjusted dose), and side effects in breastfed gastrointestinal motility disorders and gastrointestinal infants have not been reported.3,6-8 Therefore, when symptoms associated with the use of dopamine agonist nonpharmacologic treatments fail or are inadequate, Breastfeeding is recommended for all infants, with very few exceptions, as there are many benefits for Health Canada advisory
the developing child, including evidence for improved In March 2012 Health Canada released an advisory to cognitive development, reduced incidence of infec- health care professionals and to the public warning of tion, and less risk of sudden infant death syndrome.2 possible serious side effects associated with the use Further, there is evidence of benefits for the mother, of domperidone.9,10 The warning was based on 2 stud- such as reduced incidence of reproductive cancers.3 ies reporting an association of domperidone with seri- Some women, however, experience insufficient breast ous abnormal heart rhythms and sudden cardiac death milk production. Domperidone has been demon- strated to induce and maintain lactation by increas- In the first study, a nested case-control study by ing prolactin levels.4 A recent systematic review and Johannes et al,11 domperidone use was associated with meta-analysis by Motherisk demonstrated a statisti- an increased risk of serious ventricular arrhythmia (SVA) cally significant increase of 74.7% (95% CI 54.6 to 94.9, and SCD when compared with nonusers (adjusted odds P < .001) in daily milk production following treatment ratio [AOR] 1.59, 95% CI 1.28 to 1.98). The average age with domperidone and found no maternal safety issues for the cohort was 79.4 years (range 20 to 95, median when compared with placebo.5 At present, some inter- age 82); when stratified by age and sex, individuals vention trials are under way to define the appropriate younger than age 60 years and women did not have dose in specific populations (eg, mothers of preterm increased risk from domperidone exposure (OR [95% CI] 952  Canadian Family PhysicianLe Médecin de famille canadien | Vol 58: september • septembre 2012
Motherisk Update
1.10 [0.35 to 3.47] and 1.25 [0.93 to 1.67], respectively).11 2. Health Canada. Nutrition for healthy term infants. Statement of the Joint Working Group: Canadian Paediatric Society, Dietitians of Canada, and Health In the second study, a case-control analysis by van Canada. Ottawa, ON: Health Canada; 2005. Available from: www.hc-sc.
Noord et al,12 current domperidone use was associated gc.ca/fn-an/pubs/infant-nourrisson/nut_infant_nourrisson_term-eng.
php#a1. Accessed 2012 Apr 5.
with increased risk of SCD (unadjusted OR 3.72, 95% 3. Dermer A. A well-kept secret: breastfeeding’s benefits to mothers. New CI 1.72 to 8.08), but the AOR was not significant. When Beginnings 2001;18(4):124-7. Available from: www.llli.org/nb/ nbjulaug01p124.html. Accessed 2012 Apr 5.
the authors further focused on publicly insured patients, 4. Petraglia F, De Leo V, Sardelli V, Pieroni ML, D’Antona N, Genazzani AR. which included 7 SCD cases with current domperidone Domperidone in defective and insufficient lactation. Eur J Obstet Gynecol Reprod Biol 1985;19(5):281-7.
use, the AOR became significant (AOR 4.17, 95% CI 1.33 5. Osadchy A, Moretti ME, Koren G. Effect of domperidone on insufficient lacta- to 13.1). Investigators were unable to demonstrate an tion in puerperal women: a systematic review and meta-analysis of random-ized controlled trials. Obstet Gynecol Int 2012;2012:642893. Epub 2012 Feb 7.
effect of domperidone on SVA owing to an absence 6. Jantarasaengaram S, Sreewapa P. Effects of domperidone on augmentation of exposed cases. When stratified by daily dose, doses of lactation following cesarean delivery at full term. Int J Gynaecol Obstet 2012;116(3):240-3.
above 30 mg/d were associated with higher risk of SCD 7. Hofmeyr GJ, Van Iddekinge B, Blott JA. Domperidone: secretion in breast milk (AOR 11.4, 95% CI 1.99 to 65.2). This association, how- and effect on puerperal prolactin levels. Br J Obstet Gynaecol 1985;92(2):141-4.
8. Da Silva OP, Knoppert DC, Angelini MM, Forret PA. Effect of domperidone on ever, was based on only 4 individuals exposed to dom- milk production in mothers of premature newborns: a randomized, double- peridone who experienced SCD. Also of importance, the blind, placebo-controlled trial. CMAJ 2001;164(1):17-21.
9. Health Canada. Domperidone maleate—association with serious abnormal average (SD) age of the cohort of SCD cases (n = 1304) heart rhythms and sudden death (cardiac arrest)—for health care professionals. was 72.5 (14.1) years. Clearly, the populations in these Ottawa, ON: Health Canada; 2012. Available from: http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/domperidone_hpc-cps-eng.
studies are distinct from healthy breastfeeding women.12 Finally, in both studies, the data on the cases and 10. Health Canada. Domperidone maleate—association with serious abnormal heart rhythms and sudden death (cardiac arrest)—for the public. Ottawa, ON: controls were retrieved from databases. These data- Health Canada; 2012. Available from: http://hc-sc.gc.ca/dhp-mps/medeff/ bases have some limitations. One of the main limita- advisories-avis/public/_2012/domperidone_pc-cp-eng.php. Accessed tions is that the researchers were only able to examine 11. Johannes CB, Varas-Lorenzo C, McQuay LJ, Midkiff KD, Fife D. Risk of seri- if a prescription for domperidone was filled. Whether ous ventricular arrhythmia and sudden cardiac death in a cohort of users of domperidone: a nested case-control study. Pharmacoepidemiol Drug Saf or not the individual took the medication was not con- firmed.11,12 Also, in the Netherlands, where the second 12. Van Noord C, Dieleman JP, van Herpen G, Verhamme K, Sturkenboom MC. Domperidone and ventricular arrhythmia or sudden cardiac death: a population- study was conducted, domperidone is available over the based case-control study in the Netherlands. Drug Saf 2010;33(11):1003-14.
counter; therefore, all exposures to domperidone might not have been captured.12 Conclusion
Owing to the demographic characteristics of the popu-
Motherisk questions are prepared by the Children in Toronto, Ont. Ms Bozzo is Assistant Director, Dr Koren is Director, and
papers would not directly apply to healthy women of Dr Ito is a member of the Motherisk Program. Dr Koren is supported by the
childbearing age. Nonetheless, caution is advised when Research Leadership for Better Pharmacotherapy during Pregnancy and Lactation. prescribing domperidone with other drugs that prolong He holds the Ivey Chair in Molecular Toxicology in the Department of Medicine at the QT interval or with those that interfere with dom- the University of Western Ontario in London. peridone metabolism, or for women who have underly- Do you have questions about the effects of drugs, chemicals, radiation, or infections in women who are pregnant or breastfeeding? We invite you to submit Competing interests
them to the Motherisk Program by fax at 416 813-7562; they will be addressed in future Motherisk Updates.
Published Motherisk Updates are available on the Canadian Family Physician
references
1. Teva-domperidone [product monograph]. Toronto, ON: Teva Canada Ltd; 2012.
website (www.cfp.ca) and also on the Motherisk website (www.motherisk.org).
Vol 58: september • septembre 2012 | Canadian Family PhysicianLe Médecin de famille canadien  953

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