Domperidone is not currently a legally marketed human drug and it is not approved for sale in the U.S. On June 7, 2004, FDA issued a public warning that distributing any domperidone-containing products is illegal. FDA also issued an Import Alert instructing FDA field personnel to detain shipments of finished drug products and bulk ingredients containing domperidone, and refuse admission into the US. FDA took this action because of the concern about the potential serious health risks associated with the use of domperidone by lactating women to enhance breast milk production.
The risks of cardiac arrhythmias, cardiac arrest, and sudden death outweigh any potential benefit of domperidone in healthy lactating women. In addition, the concurrent use of certain commonly used drugs, such as erythromycin, could raise blood levels of domperidone and further increase the risk of serious adverse cardiac outcomes. In several countries where the oral form of domperidone is marketed, the drug's labeling specifically warns that nursing mothers should not use it. Furthermore, domperidone is excreted in breast milk, exposing a breastfeeding infant to unknown risks. However, FDA continues to recognize that there are some patients with severe gastrointestinal motility disorders that are difficult to manage with available therapy for whom domperidone’s potential benefits may justify its potential risks.
While there are currently no pharmacies that are authorized to compound domperidone under the Expanded Access program, domperidone may be obtained under certain circumstances, as described below.
Submit an IND
Patients 12 years of age and older with certain gastrointestinal (GI) conditions may be able to receive treatment with domperidone through an expanded access investigational new drug application (IND). These conditions include gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation. Patients who are eligible to receive domperidone have generally failed standard therapies.. Expanded access INDs facilitate access to investigational drugs (such as domperidone) for patients with serious diseases or conditions for which there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the patient’s disease or condition. In addition to other applicable requirements, an IND must be in effect prior to the importation, interstate shipment, and administration of domperidone.
Physicians interested in submitting an expanded access IND for domperidone can obtain more information by contacting DDI (below) to request the Domperidone Packet which contains the required forms, instructions, and answers to most questions.
Division of Drug Information (DDI):
toll free at (855) 543-3784 or (301) 796-3400