Domperidone - Condensed Info

Domperidone has been on my screen quite a bit in the past couple of weeks.  So far I've heard from a mom who needed to learn about Dom, a mom who was weaning off of Dom, a mom who is thinking about increasing Dom, and about six moms who are concerned because of the press Health Canada is getting for it's "warning."

I'm no health expert, but I do seem to be becoming something of an expert in the area of increasing and maintaining meager milk supplies.  So here is what I know for anyone who is curious...

What is it? If you want more information about the medical background of the drug (Motilium) you can find info from one of the leading Breastfeeding experts Dr. Newman on his site http://www.breastfeedinginc.ca/

I think (remember I am not an expert) Domperidone (marketed as Motilium) is an awesome resource for anyone who is truly battling a real milk supply issue.  This is not the drug of choice for a mom who gets a monthly dip due to a period - this is medicine for the mama who really needs to kick-start her supply.  
  
How much should I take? A really common concern of moms looking at domperidone is figuring out their dosage.  Looking at the link above for Dr. Newman you will see that he suggests starting out at 90mg a day (30 TID).  He also states that you can go as high as 40 mg four times a day (160mg total).

The general idea is to take three pills (that's 30mg) every 8 hours.  This is sort of the "regular dose" for moms who need the medicine to increase milk supply.  If this dose doesn't seem to be making a difference you can increase your dose to 4 pills three times a day, or three pills four times a day.  You can even go up to 4 pills four times a day!

If you are taking 4 pills four times a day, well, I haven't found any real "professional" advice on that.  Most of the ladies I know who are on the 160 regimen take their pills first thing in the morning, at lunch, at dinner, and just before bed.  A couple are really regimented and take them every six hours.  In general I see "the professionals" say that it isn't important to be really regimented about it.  Dr. Newman says "when it is convenient (there is no need to wake up to keep to an 8 hour schedule—it does not make a real difference."

When will I see a difference? Normally people start to see a little difference within a few days, but it takes two weeks to really get into your system and can take up to six weeks to see if it is really working for you.  Dr. Newman's site says "After starting domperidone, it may take three or four days before you notice any effect, though sometimes mothers notice an effect within 24 hours. It appears to take two to three weeks to get a maximum effect, but some mothers have noted positive effects only after 4 or more weeks. It is reasonable to give domperidone a trial of at least four, and better, six weeks before saying it doesn’t work."

How do I wean from Domperidone? When you are ready to stop your domperidone the general recommendation is to drop only one pill at a time.  So if you normally take 90mg a day, take 80 for a week, then 70 for a week, etc.  You can find out more from this article by Dr. Newman.

Is it really safe?  Domperidone is the safest prescription medicine that I've heard of in my journey - it is safer than Reglan according to Dr. Hale's "Medications and Mother's Milk."  Domperidone is an L1 and Reglan is an L2.  You can find out more about this here: http://www.kellymom.com/health/meds/prescript_galactagogue.html

Domperidone is also approved by the American Academy of Pediatrics.  Kellymom.com has information on this.

You may have heard about, or read, notices from the FDA and Health Canada regarding the safety of Domperidone.  Because I am not a professional I won't even try to address this myself except to say that I've done allot of research and met many mothers who use this medicine.  I personally find Dr. Newman's information to be thorough and sound so here is what he (as a professional) has to say about this issue.  To sum it all up for those in a rush - the studies were focused on people taking IV doses that are many many times higher than anything we would take for lactation.  The studies did not focus at all on lactation. 

Dr. Newman on the FDA warning.
 
Dr. Newman on the Health Canada warning:
The following excerpt is copied directly from Dr. Newman's facebook page.

Domperidone, again!

Based on a study that was published in Belgium which looked at over 1000 cases of sudden death and found that some of the people who died suddenly were taking domperidone, Health Canada has put out a warning about possible concerns about treating with domperidone. This is a bit of an overreaction on the part of Health Canada. Well, a big overreaction given the data.

Note that in the study, the youngest person who died was 55 and the average age of those who died was 75 years. What has this to do with breastfeeding mothers who are rarely older than 45 years and are usually in reasonably good health? Furthermore, this information came from a data base with no clinical information. It simply has information that so and so died suddenly and was taking such and such a drug. The thing is that domperidone in these patients was used for reflux and we know that heart disease is frequently misdiagnosed as reflux; severe pain at the top of the abdomen or lower part of the chest is typical of both reflux and cardiac pain.

Misdiagnosis is particularly possible in Europe where domperidone is
available in countries like the United Kingdom, Belgium and the Netherlands without a prescription and it is likely that many people are self-diagnosing and self-medicating.

So that's it and it does not mean that domperidone kills. I will continue to prescribe domperidone at our doses which are based on many years of clinical experience. I have treated many thousands of women with it with only minor side effects. I believe this article from Belgium proves nothing and does not require us to stop prescribing it.

It would be a pity that mothers and babies not benefit from domperidone when used in conjunction with our Protocol to manage breastmilk intake.

Furthermore he added on March 15th:

Below please find an analysis of the two studies that caused Health Canada to publish a warning about domperidone. Done by one of the paediatricians working in our clinic.

The recent Health Canada-endorsed warning about the use of domperidone was based on two studies1,2 published in 2010.

The following KEY points regarding the studies are important to highlight:

• The information in these studies was taken from databases (one in the Netherlands2 and one in Saskatchewan1) and did not demonstrate that domperidone caused any adverse health effects. To show a cause and effect, the studies would have to be, amongst other things, prospective, and these were not. There are many other limitations with these studies. For example, some key pieces of information are unavailable including smoking status, use of other non-prescription drugs, and more, all of which can be important factors1.

• The average age of the patients in the studies was 72.5 years in one2 and 79.4 years in the other1. Many of the patients in the studies had pre-existing health problems such as high blood pressure, coronary artery disease, and congestive heart failure. Thus the warnings were based on information gathered from an entirely different population than those who take Domperidone for breastfeeding purposes. Results in this age group cannot readily be applied to a younger, healthier population. In fact, in one of the studies1, the authors concluded that the risk of a cardiac problem related to taking domperidone in younger patients was much lower than in older patients. The risk quoted in younger patients was almost the same as that outcome occurring by chance alone. That study also specifies that the risk in females was significantly lower than in males. It is also important to highlight that the risk decreased the longer the patient had been on domperidone.

• The warning regarding use of Domperidone in higher doses was based on only one of the studies2; the other study1 did not include any information about dosing. In the study that included dosing information, out of the 1304 deaths that were studied, only 10 patients were taking domperidone at the time of death. Of those 10 taking domperidone, only FOUR patients were documented to be taking higher doses of domperidone (>30mg per day). Thus this Health Canada-endorsed dose-related warning came from dosing data compiled from FOUR patients total.

• Domperidone is generally used to treat gastro-intestinal problems such as acid reflux. Some of the symptoms of acid reflux (eg chest-pain) are similar to symptoms of heart disease. It is possible that some patients were taking Domperidone for what was thought to be a gastro-intestinal problem when, in fact, the symptoms may have been related to a heart problem. While the authors attempted to account for this possibility2, it is hard to tease out those taking domperidone for a gastro-intestinal symptom that was actually a heart condition.

• Furthermore, because domperidone is available over-the-counter in much of Europe specifically the Netherlands, it is possible that the number of people self-medicating with domperidone is higher than the rate actually quoted in the Dutch study (as the study only took into account prescriptions for Domperidone2 and not over-the-counter use). This important fact may have skewed the results.

• Finally, the authors of one of the studies2 suggested that “for clinicians, it is important to avoid prescribing Domperidone to patients with a high risk of sudden cardiac death”. They were not cautioning physicians not to prescribe higher doses, but simply to exercise caution in patients considered higher risk.

In summary, breastfeeding mothers using domperidone are generally younger, healthy females. They do not fall into the same demographics as the patients involved in the studies from which the warnings were generated. Furthermore, with caution about the use of higher doses of domperidone stemming from a study where so few patients were actually on those higher doses, the Health Canada-endorsed warning regarding the use of domperidone in higher doses seems to be an over-reaction. Finally, with the other drawbacks of these studies outlined above, there is no evidence that domperidone actually causes heart problems.

1 Johannes CB et al. Risk of serious ventricular arrhythmia and sudden cardiac death in a cohort of users of domperidone: a nested case-control study. Pharmacoepidemiol Drug Saf. 2010 Sep; 19(9): 881-888.
2 van Noord C et al. Domperidone and ventricular arrhythmia or sudden cardiac death: a population-based case-control study in the Netherlands. Drug Saf. 2010 Nov 1; 33(11): 1003-1014.

How do I get my hands on some? 
Please note that while the FDA has not approved this medication it is still LEGAL to purchase and use this medication in the US. If you google this you will find info, here's a quick link just to prove I'm not psychotic. 

Some countries require prescriptions and some do not.  You can find info on which countries allow the medicine OTC, or by Prescription under "clinical data" on wikipedia: http://en.wikipedia.org/wiki/Domperidone  Please remember that wikipedia is not controlled by any kind of medical professional and we should all take the info provided there with a few big grains of sea salt.

Perhaps the safest (and by far the most expensive!) way of getting domperidone is to get a prescription from a doctor or midwife and have it made for you at a compounding pharmacy.  For most mothers the compounding pharmacy thing is cost prohibitive - UNLESS!!! Some moms have found that even in the US their insurance has covered a compounded domperidone prescription!  How's that for awesome-sauce?

A second route (the one I followed) was to get someone to write me a prescription just so I felt like I'd covered my tushie and then buy the medicine online.  You can buy from pharmacies in Canada that require your prescription to be sent to them.  This medicine is not quite as costly as the compound and is shipped to you pretty quickly.  The experience of my friends has been that there are cheaper options, but I don't know anyone who has had an extended wait for their medicine to arrive.

Another online source (and by far the most popular among the people I have known to take this medication) is inhousepharmacy.biz - this pharmacy provides branded Motilium in the foil bubble packs that include all the appropriate inserts from the manufacturer.  They are the least expensive source of reliable motilium that I have found.  They are based in New Zealand and will not require you to forward your prescription (but I got one anyway).  The downside of this online store is that it takes 2 to 4 weeks for your medicine to arrive.  On rare occasions it gets held up in customs but will always be sent on to you because it IS legal.  The customs issue can add a couple of weeks to the process (that's why it's 2 to 4 weeks instead of just two weeks).

I can't think of anything to add to this, except that I hope everyone does their best research, talks to professionals who are expert in breastfeeding, and makes a choice that is right for them and their babies!  I hope that everyone remembers to take it slowly by taking the "normal dose" and then increasing appropriately until they get to their best dose... and I really hope that people who take this medicine are honest and open with their healthcare providers because even though this medicine is L1 (safest) it is still a medicine and needs to be treated as such!Best wishes to everyone!

I also encourage you to talk to nurse-midwives or lactation consultants who may have more information about this than medical doctors who are inundated with other medical subjects and may not have had the time to look into this on their own - I know I had to educate my OB on the subject!