USA. The Food and Drug Administration (FDA) is warning breastfeeding women not to use domperidone to augment lactation because of safety concerns. The agency is concerned with the potential public health risks associated with domperidone.
Domperidone is not approved in the US for any indication. Some women who breastfeed and/or pump breast milk are purchasing this drug from compounding pharmacies in the US and from sources in foreign countries. The FDA has issued warning letters to the pharmacies that compound domperidone containing products and to firms that supply domperidone to pharmacies in the US. Although domperidone is approved in several countries outside the US to treat certain gastric disorders, it is not approved in any country for enhancing breast milk production in lactating women. Worldwide there have been several published reports and case studies of cardiac arrhythmias, cardiac arrest and sudden death in patients receiving an intravenous form of domperidone that has been withdrawn from the market in a number of countries. In several countries where the oral form is still marketed, labels for the product contain specific warnings against use of domperidone by breastfeeding women and note that the drug is excreted in breast milk that could expose a breastfeeding infant to unknown risks.
FDA Talk Paper, 7 June 2004. Available on the Internet at www.fda.gov