Denver – Prescribing domperidone to support breastfeeding effectively reduced the use of infant formula without significant adverse effects in mothers and infants in a large retrospective study, Mitko Madjunkov, MD, reported at the annual meeting of the Teratology Society.
His study included 985 mothers who began taking domperidone to initiate and support breastfeeding after a visit to the International Breastfeeding Centre in Toronto. Collectively, the women had 1,005 infants.
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The study was undertaken because few data exist on the dosing and safety of domperidone during lactation. Additionally, the Food and Drug Administration issued a warning in 2004 regarding the use of domperidone as a galactagogue in response to reports of cardiac arrhythmias and sudden deaths when the drug was prescribed as an antiemetic, explained Dr. Madjunkov of the Hospital for Sick Children in Toronto.
The FDA has not approved domperidone for any indication in the United States, though it is available in Canada and other countries.
Domperidone was used by the Toronto women for a median of 20 days. The maximum daily dose was 107 mg. The infants were an average of 38 days old at the time of the visit when domperidone was prescribed and 72 days of age at their last follow-up visit related to the study.
The drug was effective as a galactagogue: 63% of women were using infant formula before going on domperidone; after using the drug, 41% were still using formula, for an absolute 22% reduction. The drug was similarly effective in promoting breastfeeding in infants with or without tongue-tie/lip-tie defects.
In total, 18% of mothers reported minor side effects. Headaches were the most common, reported by 9.2% of domperidone users. Dose reduction was employed in just 0.6% of women in the study; 0.4% of participants discontinued treatment. Rapid heart rate and other minor cardiac side effects were reported by 0.7% of women, uniformly in conjunction with trigger factors such as anxiety or caffeine use, but none of these women discontinued treatment. No treatment-associated adverse effects occurred in the infants.
Dr. Madjunkov reported having no financial conflicts related to his study.