I noticed a post regarding Domperidone in the United States and thought I would copy the article below from the US Lactation Consultant Association September eNews regarding Domperidone. 


Marsha Walker, RN, IBCLC
Weston, MA


Over the last few months, USLCA has been working in conjunction with Dr. Thomas Hale from 
the Infant Risk Center at Texas Tech University towards obtaining approval from the Food and 
Drug Administration (FDA) for the use of Domperidone for breastfeeding mothers experiencing 
insufficient breastmilk. U.S. Clinicians have long been unable to (or only with difficulty) offer 
this option to selected mothers experiencing 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, 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, but the orphan 
status qualifies for grants to conduct such 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 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 working on the next stage 
of this process which is to apply for grants to conduct the FDA required clinical trials with the 
hope of eventually obtaining marketing approval for Domperidone. Dr. Hale has been instrumental in collecting the required information and filing the application for orphan drug status. 
His intense work and command of the subject were invaluable in making it this far. While the 
process for FDA approval of the use of Domperidone is a lengthy one, we are well on our way 
to hopefully being able to provide this option for the mothers who may need it so desperately.

 

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