The US Lactation Consultant Association (USLCA) last week announced that the first step in an effort to make the medication domperidone (brand name Motilium) more widely available for use in increasing milk supply has been achieved.
First, some background: Domperidone is considered a highly effective galactagogue. It's an anti-reflux drug that has the side effect of increasing milk supply. It is available over-the-counter in the U.K and other developed countries but only by prescription in the U.S., and it must be ordered at a compounding pharmacy.
Medications and Mothers' Milk says domperidone is "considered the ideal galactagogue," and labels it an "L1" on the L1 to L5 scale, placing it in the "Safest" category. The American Academy of Pediatrics rates it as "usually compatible with breastfeeding."
In 2004 the Food and Drug Administration issued a warning that domperidone could induce arrhythmias in patients. Medications and Mothers' Milk states, "These claims were derived from data many years old where domperidone was used intravenously as an antiemetic during cancer chemotherapy. Many of these patients were undergoing extensive chemotherapy, were extremely ill, and hypokalemic to begin with. In addition, intravenous domperidone produces plasma levels many times higher than oral use. Thus far, we do not have any recent published data suggesting that domperidone used orally in breastfeeding mothers is arrhythmogenic, although its use in women who are already arrhythmic is not recommended."
Because of this there is a lot of confusion about domperidone, and it's rarely used here.
Now on to this weeks' news. The USLCA reports:
Over the last few months, USLCA has been working in conjunction with Dr. Thomas Hale from the Infant Risk Center at Texas Tech University [author of Medications and Mother's Milk] towards obtaining approval from the Food and Drug Administration (FDA) for the use of domperidone for breastfeeding mothers experiencing insufficient breastmilk. Clinicians in the U.S. have long been unable to (or only with difficulty) offer this option to selected mothers experiecing insufficient milk production.
The first step in this process was to obtain orphan drug status for Domperidone. The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. The approval of an orphan designation does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and efficacy must still be established through adequate and well controlled studies.
The FDA granted orphan drug status to domperidone for "treatment of hypoprolactinemia in breastfeeding mothers, and in some hypoprolactinemic conditions following the use of cabergoline or bromocriptine [drugs used to suppress lactation] in mothers who wish to return to breastfeeding." Once the required studies are conducted, they are submitted to the FDA for final marketing approval. USLCA and Dr. Hale are beginning to work on the next stage of this process, which is to apply for grants to conduct the FDA required clinical trials which the hoipe of eventjually obtaining marketing approval for Domperidone.
The USCLA states that Dr. Hale's command of the subject matter and work in submitting the required information was invaluable in this effort.
So there is some hope that domperidone may be approved for use to increase milk supply in the future, and its availability may dramatically improve.
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