This commentary serves to raise health care provider awareness about the regulatory status and available evidence regarding domperidone for insufficient lactation. Breastfeeding provides significant health benefits for mothers and infants, and insufficient milk production remains the most common reason for early weaning. Domperidone, a dopamine receptor antagonist that may increase milk production, is not approved for any human use in the United States. It is approved in some countries for certain gastrointestinal disorders, but is not approved in any country for lactation enhancement. Domperidone is associated with serious cardiac arrhythmias. The U.S. Food and Drug Administration (FDA) issued an import alert in 2004, updated in 2012, explaining that the importation of domperidone is illegal with limited exceptions, including when imported pursuant to an investigational new drug application. The FDA also issued a public safety warning regarding the use of domperidone for lactation. Nonetheless, domperidone is sometimes being obtained illegally and used in attempts to increase milk production in lactating mothers. There is limited quality evidence for the effectiveness of domperidone for lactation enhancement. In contrast, considerable information exists on domperidone's cardiac risks including QT prolongation, torsades de pointes, and sudden cardiac death, including among lactating women. In light of limited efficacy data that do not offset safety concerns from a public health perspective, we continue to caution against using domperidone for lactation enhancement. Research and drug development are needed to address the significant unmet medical need for lactation disorders.
In light of efficacy data that do not offset the concerns for cardiac risks, the U.S. Food and Drug Administration cautions against using domperidone for lactation enhancement.
Office of New Drugs, the Office of Drug Evaluation III, the Division of Bone, Reproductive, and Urologic Products, the Office of Surveillance and Epidemiology, the Office of Pharmacovigilance and Epidemiology, and the Division of Pharmacovigilance II, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland.
Corresponding author: Christina Y. Chang, MD, MPH, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, MD 20993; email: firstname.lastname@example.org.
Financial Disclosure The authors did not report any potential conflicts of interest.
The authors thank their colleagues in the Division of Pharmacovigilance II (Neha Gada), the Drug Utilization team (Mohamed Mohamoud and Grace Chai), and the Division of Epidemiology II (Joel Weissfeld, Jie Li, and David Moeny) for review of the U.S. Food and Drug Administration Adverse Event Reporting System data, drug use data, and pharmacoepidemiologic studies.
Each author has indicated that she has met the journal's requirements for authorship.