Domperidone Use for Increasing Milk Production

Domperidone has been prescribed to women to support lactation. There have been warnings about this drug causing arrhythmias (irregular rhythms in the heart). Most of the studies showed harm with high doses (given intravenously) and also in people with other illnesses that could potentially increase their risk of arrhythmia. Certain populations should never take domperidone such as those with an underlying heart dysrhythmia, those with liver disease, or people taking certain medications that could affect domperidone’s action.

Most studies on adverse effects of domperidone have looked at doses of 30 to 60 mg/day. These studies describe the following most commonly reported adverse effects: dry mouth, transient skin rash or itching, headache, thirst, abdominal cramps, diarrhea, drowsiness, and nervousness.

In March 2012, Health Canada endorsed an advisory statement, published by Teva Canada Limited, indicating that health practitioners should exercise caution when prescribing domperidone at doses greater than 30mg/day. The advice is based on the theoretical risk that higher oral doses of domperidone can trigger ventricular arrhythmias and sudden cardiac death. As detailed in the attached article, the justification for this advisory, especially in young breastfeeding women, is not supported by the scientific literature. Of primary concern is the likelihood that, based on the warning, many health practitioners will discontinue prescribing domperidone to mothers who would otherwise require it to support and sustain breastfeeding. As a consequence, numerous babies who would have otherwise breastfed will not. The adverse consequence of not breastfeeding along with the resultant introduction of artificial nutrition in infancy, carry serious associated morbidity and mortality for which there is scientifically solid, prolific, and compelling evidence.

Most studies on domperidone for lactation use a starting dose of 30 mg/day. No studies to date have looked at safety and efficacy of dosage titration up to a maximum dose. Amongst lactation specialists in Canada, domperidone is being prescribed in doses ranging from a starting dose of 30-90 mg/day to a maximum dose of 80-160 mg/day. Of the thousands of mothers the authors of this statement have collectively treated with domperidone for the purposes of breastfeeding support, no one is aware of a single case of maternal death from ventricular arrhythmia. In fact, Health Canada’s Canada Vigilance Program has confirmed that between 1965 and 2011, there were no cardiac-related deaths reported among women taking domperidone.

For more information, please see the following article