Domperidone for NICU mom

[jen-rnc-ibclc]

I had no idea the extent of the FDA crackdown on domperidone so I advised a brestfeeding mother with a history of reduction mammoplasty to ask her MD for a prescription. The MD complied after I supplied her with a stack of information on the med including Dr. Hale's position. Of course, no pharmacy I know of can now fill that Rx. It is only available as an NDI according to all the compounding pharmacies that I have contacted. To make matters worse, a breastfeeding counselor (not an IBCLC) came after me and told this sweet little momma that the drug is dangerous and not FDA approved. She has lost all confidence in me as an IBCLC and an RN.

What options are left? One pharmacist mentioned something in a return phone message about changes on the horizon in the next few months?

If you have information to share, PLEASE do. For some moms, this drug is a true miracle and a last hope.

--Jennifer, BSN, RNC-MNN, IBCLC

[admin]

Jen:

I'm sorry for your difficulties in obtaining domperidone. You are correct, the FDA is exceedingly sensitive about this drug and I know why, as there are a set of studies suggesting it produces arrhythmias in humans, mostly old males > 72 years of age. But the fact that this body of literature exists has made them sensitive to this drug.

I submitted an IND for a study, but they placed it on hold and are requiring a major change in my study design. I hope to resubmit soon.

As far as something new on the horizon, I know of nothing of the sort. As of this time, you are stuck with metoclopramide for no more than about 30 days. I know its horrible, but this is all we have. Domperidone is available in Mexico, Canada, and virtually every other country in the world.



Tom Hale Ph.D.