FDA Updates Guidance: How to Request Domperidone for GI Disorders

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    Cain-TeddACG continues to work with the FDA in helping members obtain access to domperidone for patients.  As you know, 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.  According the FDA, 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. Also, 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.

    However, patients 12 years of age and older with certain gastrointestinal (GI) conditions who have failed standard therapies can 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.

    How to Get Domperidone for Gastrointestinal Disorders

    This guidance updates the pharmacies by which ACG members can access domperidone.  However, the IND process is still required.  ACG continues to work on your behalf to streamline and improve this IND process.

    Contact ACG or your ACG Governor if you or your practice is experiencing difficulty in accessing domperidone for patient.

    Tedd P. Cain, MD, FACG

    ACG FDA Related Matters Committee Chair,
    ACG Governor for Wisconsin

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