How to Request Domperidone for Expanded Access Use
Update: FDA was informed in late 2022 that the current supplier of domperidone was exiting the business due to transfer of ownership of the product to another company and, as such, will no longer supply domperidone tablets for treatment use under expanded access. Efforts made in the interim to identify an alternative source have been unsuccessful. The current supply will be exhausted as early as the first or second quarter of 2025, at which time this program will no longer be able to supply domperidone for treatment use under your expanded access IND. FDA understands that this may pose challenges as you continue to care for your patient(s). We are making you aware of this development now so that you may begin to explore other treatment strategies.
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 for Use in Humans
Domperidone is not currently a legally marketed human drug and it is not approved for sale in the U.S. for human use. FDA issued a warning in 2004 that stated that distributing domperidone-containing products for human use is illegal. Additionally, domperidone cannot be legally compounded for humans because the use of domperidone does not meet the conditions for compounding under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act. The quality of illegally imported and compounded domperidone cannot be assured.
In 2004, FDA published a warning about cardiac-related risks with the use of domperidone to increase lactation. 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.
In 2023, FDA completed a review of cases to evaluate neuropsychiatric adverse events associated with the discontinuation or attempted discontinuation (slow dose-reduction) of domperidone when used for lactation. FDA identified six cases reporting various adverse events, including agitation, anxiety, attempted suicide, confusion, insomnia, intrusive thoughts, homicidal ideation, obsessive thoughts and suicidal ideation. FDA’s findings provide sufficient evidence to suggest a potential association between the development of neuropsychiatric adverse events upon the sudden discontinuation or tapering of domperidone when used for lactation.
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.