GOLD Lactation Conference News
Domperidone and Breastfeeding
Category: Articles
Author: Dr. Frank Nice, RPh, DPA,CPHP
Two drug products available for off label use as galactogogues are domperidone and metoclopramide. Domperidone is not approved as a prescription drug in the United States. Domperidone currently is used worldwide as an anti-nausea agent for adults, children, and women. It is currently available in 60 countries including Canada and Mexico. Domperidone was recently given Orphan Drug designation for the treatment of hypoprolactinemia in breastfeeding by the Food and Drug Administration (FDA) in the United States. The Orphan Drug Act provides incentives for the development of drugs for the treatment of Rare Diseases. Hypoprolactinemia has been designated as a Rare Disease. A scientific rationale for the use of domperidone to treat hypoprolactinemia exists.
Over 60,000 cases of hypoprolactinemia are reported annually in the United States. Infants who do not receive human milk in the United States cost its healthcare system over $13 billion each year and result in over 900 unnecessary infant deaths annually. Domperidone can produce significant increases in prolactin with subsequent increases in milk production. No drug is currently approved for the condition of hypoprolactinemia of lactation in any country. As was stated, domperidone is not approved as a prescription drug in the United States. This is not necessarily due to safety or lack of effectiveness issues, as much as to do with marketing and economic issues
Domperidone can and does increase milk production. It has less side effects than metoclopramide since does not pass the blood-brain barrier. Practical information on domperidone dosing and withdrawal of the drug (both for sufficient milk supply and for insufficient milk supply) has been developed and is available for breastfeeding mothers to apply and use. The usual dosage of domperidone is usually two 10 mg tablets four times a day. It can also be three 10 mg tablets three times a day. Additional dosing regimens exist. Most breastfeeding mothers take the drug for three to eight weeks. Milk supply usually increases in about three to four days but may take up to two to four weeks, or more. A trial for at least four weeks should be used. A mother using domperidone should discuss all possible side effects, drug interactions, and contraindications with her doctor, pharmacist, and lactation consultant. Domperidone can be purchased from reputable pharmacies in Canada and is also is available with a doctor’s prescription from certain compounding pharmacies in the United States.
Dr. Frank Nice will be presenting at this year's GOLD Lactation Online Conference. To learn more about Dr. Frank Nice & his presentation, please click here.
