What does FDA have against Domperidone?

[AislinCarys]

I used Domperidone, got it prescribed by my doctor in New Zealand. Currently I live in Sweden, and am involved in a breastfeeding support network. Here, Domp. can't be sold or prescribed, and it is apparently illegal to import drugs from outside the EU.

I've met mums who would love to try Domperidone (donor milk is rare outside the premie ward, so it is formula that is their only other option - most of them would just want to keep breastfeeding in some way anyway). So we've talked bout it, there are others in the network who would love to be able to recommend Domperidone to mothers in need.

However, from the medical establishment (nurses, pharmacists etc) we are met with the "fact" that "Domperidone transfers into breastmilk, and is very dangerous", and a reference to US FDA.

My question therefore is what does the FDA have against Domperidone? What is the reason they warn against prescribing it? I didn't find it on their page, just some nonsense about "no country having it licensed for increasing milk production" (which might be true, but there are definitely countries where it is prescribed for increasing milk production). If we are going to be able to meet this claim, it would really help to know what the FDA based their warning on.


Mods: Please move if this should be in Breastfeeding.

[mammamo]

I don't have a med book here or i would look it up...but i *think* it causes EKG changes that can be dangerous

[Sk8ermaiden]

The studies show that the only time it is dangerous is when it is injected into the IVs of patients who already have heart problems. (And I think the claims of that study were later refuted anyway.) The studies have shown that almost no Dom gets into breastmilk at all. (I don't have the data on hand, but it is less than .1% I believe.)

The reason is it not FDA approved here is that it is for reflux, and we have so many drugs here already prescribed for than that they did not bother to go through the expensive testing to be approved here - they would have too much competition to make it worth their while.

This is what I can gather from all my research and talking to LCs. It is not approved here because they never went though the entire process to GET it approved.

Dr. Jack Newman has lots of information.
http://www.drjacknewman.com/help/Dom...%20Started.asp

[mambera]

http://www.fda.gov/Drugs/DrugSafety/.../ucm173886.htm

The issues they point out are the arrhythmia/MI/sudden death issue and the transfer-into-milk issue.

As noted, the arrhythmia thing seemed mostly to be a problem with the IV formulation - although I did see a forum post from one mom who reported heart palpitations with oral domperidone (she prudently stopped the drug and the palpitations went away). Some moms do take this drug in doses way beyond what's used for reflux.

At the time of the FDA statement (in 2004) I don't think there was any information out there about the degree to which dom transfers into milk. Since then there has been one study of which I am aware, which found that the babies' serum level was about 1/10,000 of the maternal serum level.

http://www.ncbi.nlm.nih.gov/pubmed/18507654

[PatioGardener]

Yeah, as the PPs said it was heart arrrhythmias (and deaths as a result) in sick patients who had it given through the IV in large doses that caused the FDA troubles. Too bad they can't see that oral is aborbed differently!

I know several clinics in Canada who screen mothers before preescribing it - asking about personal and family history of heart issues, sudden unexplained deaths and unexplained fainting (also symptoms of arrhythmias.) They also caution mothers to avoid certain medication while taking domperidone, and to avoid grapefruit as well. That approach seems to me to be much more reasonable than not having it available to moms in need!

[khaoskat]

One thing to be noted, is that the FDA would rather have mother prescribed an off use medication that crosses the blood-brain barrier and causes depression and potentially suicide. Reglan is not FDA approved for increasing milk either, but it is often prescribed for it.