A controversial medication used by breastfeeding women should not be restricted in Australia because of the benefits it offers mothers and their babies, according to researchers at the University of Adelaide.
The medication domperidone has recently been the subject of warnings from the European Medicines Agency based on research that there is a link between the medication and fatal heart conditions.
Domperidone has been banned in the United States for years because of fatal cardiac arrhythmias among cancer patients who had been prescribed the drug to prevent nausea and vomiting.
However, in many countries, including Australia, domperidone is used to help women experiencing difficulties with breastfeeding, as it's known to increase milk supply. In line with the overseas experience, Australia's Therapeutic Goods Administration is currently reviewing the need for further restrictions on the use of domperidone.
"There are currently calls for domperidone to be banned for use or heavily restricted because of claims it also puts mothers' lives at risk, but there is absolutely no evidence of this," says NHMRC Early Career Fellow Dr Luke Grzeskowiak (pronounced: Grez-ko-vee-ak) from the University's Robinson Research Institute.
"Unfortunately the different uses of the medication have been tied into the one outcome – fatal cardiac arrhythmia. But its use in older and sicker patients compared with nursing mothers is completely different.
"The risk of fatal heart conditions was seen to be increased primarily in men, and among people aged over 60 years. No studies to date have shown an increased cardiac risk from domperidone for women trying to breastfeed," Dr Grzeskowiak says.
In a letter published in the Journal of Human Lactation, Dr Grzeskowiak says despite its use being "off-label", domperidone remains widely used in clinical practice for women experiencing low milk supply, with no reports of significant adverse effects.
"In contrast, recent research has demonstrated that domperidone is well tolerated by breastfeeding mothers and is associated with modest improvements in breast milk volume. This is important, as breastfeeding is associated with significant reductions in infant disease and mortality, as well as providing long-term benefits for the mother, with reductions in the incidence of certain cancers," he says.
"These wide-ranging benefits should outweigh what amounts to largely theoretical risks associated with the use of domperidone for low milk supply. Further restrictions regarding the use of domperidone for lactation do not appear warranted and risk subjecting breastfeeding women to further emotional trauma as well as not being in the interests of the long-term health of them or their babies."
Dr Luke Grzeskowiak
NHMRC Early Career Fellow
Robinson Research Institute
The University of Adelaide
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