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FDA warns against women using domperidone to increase milk production.
2004 JUL 1 - (NewsRx.com & NewsRx.net) -- In response to reports that women may be using an unapproved drug, domperidone (Motilium; manufacturer: Janssen), to increase lactation, the U.S. Food and Drug Administration (FDA) is warning breastfeeding women not to use this product because of safety concerns.
On June 7, 2004, FDA also issued six letters to pharmacies that compound products containing domperidone and firms that supply domperidone for use in compounding.
The Agency also issued an Import Alert, which alerts FDA field personnel to be on the lookout for attempts to import this drug so that it can be detained and refused admission into the U.S. if appropriate.
FDA took these actions because it has become aware that some women who breastfeed and/or pump breast milk are purchasing 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 U.S. to treat certain gastric disorders, it is not approved in any country, including the U.S., for enhancing breast-milk production in lactating women and is not approved in the U.S. 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 ...
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Source: HighBeam Research, FDA warns against women using domperidone to increase milk production.