Issue Date: June 14, 2004
FDA issues warning on domperidone
FDA is warning women not to use the unapproved drug domperidone to increase their milk production. According to several case studies, the drug caused arrhythmia, cardiac arrest, and sudden death in some patients receiving the intravenous form of the drug. It is approved only for gastric distress in some countries, but not for enhancing lactation. In the U.S., it has not been approved for any use. Women are purchasing the drug from compounding pharmacies and from foreign sources over the Internet, according to FDA. Domperidone, which is excreted in breast milk, is touted on several websites as safe and effective for milk production because the compound may increase the secretion of prolactin, a hormone that is needed for lactation. FDA also issued six warning letters to compounding pharmacies that sell domperidone and to firms that supply the drug for use in compounding.
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