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Drug safety

Breastfeeding mothers may lose out if recent domperidone warnings are heeded

The benefits of using domperidone to increase milk supply in breastfeeding mothers outweigh risks associated with the drug, according to the author of a letter published in the Journal of Human Lactation[1].

Luke Grzeskowiak, a researcher at the University of Adelaide, South Australia, says that recent calls to restrict domperidone because of its potential to cause cardiac toxicity would potentially deny the benefits of breastfeeding to mothers and their babies.

“Evidence from a recent systematic review and meta-analysis demonstrated that domperidone is well-tolerated by breastfeeding mothers and is associated with modest improvements in breast milk volume[2],” writes Grzeskowiak. “This is important, as breastfeeding is associated with significant reductions in infant morbidity and mortality, as well as providing long-term benefits for the mother.”

In March 2014, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (EMA PRAC) reviewed the evidence for domperidone-containing medications. It concluded that the risk–benefit profile favoured domperidone in the symptomatic management of nausea and vomiting when given at low doses and for short periods of time, but not in the management of heartburn, bloating or relief of stomach discomfort.

However, the committee did not evaluate evidence surrounding domperidone for “off-label” indications, such as in women experiencing low milk supply. “This raises significant questions regarding the relevance and generalisability of this EMA PRAC recommendation,” writes Grzeskowiak, who notes that domperidone has been shown to be associated with an increased risk of sudden cardiac death only in people older than 60 years and in men.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20067202

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