Drugs

Domperidone – How to Obtain

Domperidone is not currently a legally marketed drug or approved for sale in the U.S. On June 7, 2004, FDA issued a warning that compounding domperidone is illegal, and issued an import alert advising FDA field personnel that they may detain shipments of finished drug products and bulk ingredients containing domperidone. This warning was the result of the Agency's concern about the potential public health risks associated with the use of domperidone by lactating women to enhance breast milk production (i.e., the risk of cardiac arrhythmias, cardiac arrest, and sudden death outweigh the potential benefit of domperidone use in this population). However, FDA recognized that there are some patients with severe gastrointestinal motility disorders that are difficult to manage with available therapy, who may benefit from domperidone and in whom domperidone’s potential benefits outweigh its risks.

FDA currently allows patients 12 years of age and older with various gastrointestinal (GI) conditions to be treated with domperidone through the Expanded Access to Investigational Drugs program. These conditions include gastroesophageal reflux disease with upper GI symptoms, gastroparesis, and chronic constipation. Patients must have failed standard therapies to be eligible to receive domperidone. This program facilitates access to investigational drugs, (such as domperidone) for patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the patient’s disease or condition. Authorization must be obtained from FDA prior to the importation, interstate shipment, and administration of domperidone.

Physicians interested in obtaining expanded access for domperidone must submit an investigational new drug application (IND). An IND is a request for FDA authorization to administer an investigational new drug (e.g., Domperidone) to humans. Such authorization would allow the importation, interstate shipment, and administration of the drug even though it is not approved for sale in the U.S.

Physicians can obtain Domperidone for a single patient or multiple patients 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
email: druginfo@fda.hhs.gov

Page Last Updated: 08/20/2014
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