United States of America Food and Drug Administration Warns Against Women Using Unapproved Drug, Domperidone, to Increase Milk Production

In response to reports that women may be using an unapproved drug, domperidone, to increase milk production (lactation), the Food and Drug Administration (United States of America Food and Drug Administration) is warning breastfeeding women not to use this product because of safety concerns. Today, United States of America Food and Drug Administration also issued six letters to pharmacies that compound products containing domperidone and firms that supply domperidone for use in compounding.

The Agency also is issuing an Import Alert which alerts United States of America Food and Drug Administration field personnel to be on the lookout for attempts to import this drug so that it can be detained and refused admission into the United States of America if appropriate.

United States of America Food and Drug Administration took these actions because it has become aware that some women who breastfeed and/or pump breast milk are purchasing this drug, domperidone, from compounding pharmacies and from sources in foreign countries to increase breast milk production. Domperidone may increase the secretion of prolactin, a hormone that is needed for lactation.

Although domperidone is approved in several countries outside the United States of America to treat certain gastric disorders, it is not approved in any country, including the United States of America , for enhancing breast milk production in lactating women and is also not approved in the United States of America for any indication.

The agency is concerned with the potential public health risks associated with domperidone. 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arrhythmias, cardiac arrest, and sudden death in patients receiving an intravenous form of domperidone that has been withdrawn from marketing in a number of countries. In several countries where the oral form of domperidone continues to be 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. Because of the possibility of serious adverse effects, United States of America Food and Drug Administration recommends that breastfeeding women not use domperidone to increase milk production.

The United States of America Food and Drug Administration recognizes the immense health benefits that breast milk provides for a nursing infant and is taking these actions today not to discourage women from breastfeeding but rather to warn them not to use this particular drug while they are breastfeeding.

The letters issued by United States of America Food and Drug Administration today stated that all drug products containing domperidone (whether compounded or not) violate the Federal Food, Drug, and Cosmetic Act (the Act) because they are unapproved new drugs and misbranded. In addition, distribution within the United States of America , or importation of domperidone-containing products, violates the law. United States of America Food and Drug Administration informed the warning letter recipients that further violations of the Act may result in enforcement actions including seizure and injunction.