How to Request Domperidone for Expanded Access Use
Contact
Division of Drug Information (DDI):
toll free at (855) 543-3784 or (301) 796-3400
email: druginfo@fda.hhs.gov
Background and Important Safety Information
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 serious risks associated with domperidone include cardiac arrhythmias, cardiac arrest, and sudden death. These risks are related to the blood level of domperidone, and higher levels in the blood are associated with higher risks of these events. 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.
How to Get Domperidone for Gastrointestinal Disorders
FDA recognizes 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. Patients 12 years of age and older with certain gastrointestinal (GI) conditions who have failed standard therapies 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.
Physicians
Physicians interested in submitting an expanded access IND for domperidone can download the Domperidone Packet which contains the required forms, instructions, and answers to most questions or contact DDI (above) to discuss domperidone. For those physicians interested in treating only one patient, the consolidated FDA Form 3926 can be used in lieu of the 1571 and 1572 forms. Physicians that anticipate treating more than one patient in one year are advised to submit an intermediate size (multi-patient) IND. Multi-patient INDs allow for consolidated reporting and less administrative paperwork in the long-run.
Patients
Please have your physician download the Domperidone Packet or contact DDI (above) to discuss domperidone.
Pharmacies
If you are interested in distributing domperidone to IND holders under the FDA’s expanded access program, please contact DDI (above) to discuss domperidone.