The (Not So) Great Canadian Domperidone Debacle

domperidone

Last week, Health Canada and Teva (a drug manufacturer) released a public advisory warning against the use of a medication called Domperidone under the following circumstances:

  • If patients are Elderly
  • When taken with other drugs, such as ketoconazole
  • If patients have heart disease
  • If patients have low potassium and/or magnesium
  • If the domperidone dosage is higher than 30 mg per day

Though not considered or discussed in this document, this advisory may undermine success for mother-baby dyads struggling to successfully breastfeed. The use of domperidone for breastfeeding problems is common practice among lactation physicians across Canada. The drug increases mother’s levels of prolactin, a hormone that promotes lactation. Without the availability of this medication, I suspect that a significant number of mothers will fall short of achieving their breastfeeding goals.

I very commonly prescribe domperidone to lactating mothers who have low breastmilk supply and/or flow. The starting dose is 90 mg per day and I sometimes bump up the dose to as high as 120 to 160 mg per day – 5x the maximum recommended dose in the advisory! In fact this prescribing practice is standard of care among Canadian lactation specialists – with some variation from clinic to clinic. Interestingly, in the decades that domperidone has been used at these higher doses for lactation support, Canada Health has not received any adverse reaction reports of serious heart-related problems “in relation to the use of domperidone used to stimulate milk production in breastfeeding women.” 

The big question, now, is what are breastfeeding mothers on domperidone to do in light of this advisory. And what about the healthcare providers who prescribe/dispense domperidone on a daily basis? Doctors have already started calling breastfeeding patients on domperidone to strongly recommend discontinuing the medication immediately. Pharmacists are doing the same. I suspect that this type of intervention will not ‘save’ any lives, but will disrupt breastfeeding for thousands of current and future mother-baby dyads. Since not breastfeeding is associated with health-risks for baby and mother, there is significant morbidity and mortality that is likely to arise as a consequence. I propose a more sensible and prudent approach:

  1. Mothers on domperidone who are experiencing heart palpitations, dizziness, fainting, or seizures should stop taking the medication and get medical help immediately.
  2. Mothers who are well established on domperidone and without any of the above symptoms should contact a healthcare provider familiar with lactation medicine for further guidance. Some good resources include
    a. The Newman Breastfeeding Clinic and Institute 
    b. Better Breastfeeding Clinic 
    c. The Goldfarb Breastfeeding Clinic
  3.  Healthcare providers who practice lactation medicine should get together and critically review the literature pertaining to the use, efficacy, and risks of domperidone specifically in breastfeeding mothers. This process has been initiated.
  4. After the above review, a position statement should be published giving expert-opinion-driven guidelines that can serve as a reliable reference for healthcare practitioners who wish to support lactation with this medication.

I will periodically update this post with new information as it arises. Do feel free to comment below.

Addenda:

2012/05/11 – A consensus statement, composed/endorsed by 22 breastfeeding across Canada

see A Consensus Statement on the Use of Domperidone To Support Lactation

2012/05/11 – A Response to Health Canada Regarding the March 2nd Domperidone Advisory 

see Letter to Health Canada

2012/03/15 – A critical review of the scientific papers upon which the advisory’s authors based their recommendations.  

See Domperidone study limitations

 

2012/03/10 – Comments from Dr. Howard Mitnick, Goldbarg Breastfeeding Clinic:

This is an important public health issue. The health risks associated with early discontinuation of breastfeeding in Canada is very well established and very large. Correspondingly, the data for moms taking domperidone demonstrates that the actual cardiac risk to Canadian mothers is theoretical at best.


2012/03/10 – Comments from Dr. Jack Newman, Newman Breastfeeding Clinic and Institute

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.

If you live in Toronto and would like nutrition support for your child, feel free to learn more about the Kindercare Pediatric’s clinical nutrition programs.

  • a voice of reason! Well said. Any mums who are already taking Domperidone should NOT stop cold turkey as this has been associated with mood issues.

  • Well done, Dr Flanders. Your argument is sound. This is an important public health issue. The health risks associated with early discontinuation of breastfeeding in Canada is very well established and very large. Correspondingly, the data for moms taking domperidone demonstrates that the actual cardiac risk to Canadian mothers is theoretical at best.

  • Frustrating to throw out the good at the blush of a worry. It makes sense, though, from Teva’s business perspective. I believe they market formula in various countries. They probably make more money that way than through domperidone for moms.

  • Can you please clarify a few things for me? This drug is secreted in the breast milk, and no studies have ever been done on how it affects babies, it also is not classified as a lactation aid, so why is it that a warning that comes out about some of the risks should be ignored? There are other drugs that are used in similar ways (cytotec, comes to mind) where the side effects can be used for some other purpose and many people cry foul and want these drugs banned. What about all the anti- vaxers? Many of the non-vaxers use the argument of ‘not knowing long term effects’, ‘test subjects are not the same as ones being given the vaccine’, ‘doses are tested as individual shots and not mixed with other vaccines( the dosage of this drug for lactating women is pretty high)’, ‘what about those people who die or are damaged from the vaccines, don’t they count?’. This could all be applied to this medication as well. This drug was created for GI problems and it is secreted in breast milk. There have been other drugs that have been used for stuff they haven’t been approved for and years later data comes out showing that maybe there was a reason for that. I know because it is about breast feeding it must be just the formula companies way to shut down any help for breast feeding, it wouldn’t have anything to do with maybe these people are privy to some really bad side effects that they might be seeing.

  • Thank you for your thoughtful comments. I’ll address your various points:

    1. Regarding your comment about no studies being done on how domperidone affects babies.

    Domperiodone has actually been prescribed and studied extensively in babies for years. This data is available because for decades, domperidone has been used (and still is)b to treat gastroesophageal reflux and slow gastric motility in infants and children. This is a rich and controversial story, but beyond the scope of this particular blog post.

    2. Regarding your comment about adverse effects and sife effects of medications going unaddressed.

    There is always risk one faces when taking any medication (or undergoing any treatment/procedure). In deciding whether or not to prescribe (doctor) or take (patient) a given medicine, the patient and doctor must undergo the process of informed consent. This requires that there is a frank and objective discussion between doctor and patient laying out the hopeful benefits of the proposed medication weighed against risks of side effects and adverse events that may arise as a consequence of taking the medication. Ultimately, the patient makes the decision for herself whether the benefits outweigh the risks and then whether to proceed with treatment. If this dialogue happens as it should, then medicine is being practiced appropriately, considerately, and responsibly.

    3. Regarding your feelings about vaccinations.

    There are many venues out there for sharing, discussing, and debating the virtues and risks of vaccinations. I would like to keep the focus of this blog post/comments squarely on domperidone and lactation. By all means, please feel free to engage in vaccination-related discussions on vaccine-related posts – both on this and/or other sites.

    Thanks again for your insights and comments.

  • PhD_Mom

    Domperidone saved my chance at b-feeding my older child about a decade ago and now it’s not available even by prescription in the U.S. (where I am) – I learned through the grapevine that formula companies funded the lobbyists that helped make it unavailable here. Come on Canada, don’t follow our bad example!

  • Thanks for this argument. We’ve included it in a post we did in French on domperidone. Strange that the Quebec media didn’t report (yet) this Health Canada advisory…

    http://bienvivrelallaitement.wordpress.com/2012/03/13/controverse-sur-la-domperidone-encore/

  • It is already very difficult to get physicians to script dom in the US, at least in the south where I’ve always worked (22yrs). Even if you get a script, compounding pharmacists are already reluctant to fill it due to the FDA idiocy.

    I have always thought that there HAS to be a formula-industry connection. When I read that the manufacturer itself is also (perhaps?) in the formula business, my immediate reaction was “AHA!”

    The big problem is that the majority of physicians simply don’t believe in breastfeeding. Perhaps there is carryover guilt on their parts for having been the biggest reason BF went away (remember where the word “formula” comes from!), and reluctance to have to admit even in their own minds that they were wrong. “first do no harm” doesn’t seem to apply unless it is convenient.

    So sad.

    For the babies – and you docs out there working so hard, PLEASE don’t give up! we rely on you worldwide as voices of reason in a dollar-driven world.

  • Thank you for talking about this. DPD gave me the opportunity to nurse my child as I had breat reduction surgery. Had it not been for DPD I would have no milk for my child.

  • Thanks for taking the time to respond to my comments. Can you reference any studies that have been done on infants who have received this drug via breast milk and did not have GI problems before? There is risk in everything in life but I am just curious as to why when some risks are acceptable and others aren’t. So this drug blocks dopamine receptors, so do these infants need their dopamine receptors blocked? Are there long term effects that will be seen when these children are older?

    Maybe people should be asking the question as to why there is such an increase in women who cannot produce enough breast milk. I was lucky to have not had issues nursing any of my many children. If I noticed a decrease in supply I would look at what I was putting in my body and how that might be affecting my production. I also would look at my life and see if there were triggers that might be affecting my supply.

    I was not trying to start a vaccine debate, I was just pointing out parallels to that and this drug.

    Thanks again for your reply.

  • I am not aware of any studies done looking at the impact on infants of receiving breastmilk from moms who take domperidone. Only a very small amount of domperidone actually makes it into the breastmilk. And then that small amount is significantly degraded in the baby’s gut before absorption into the bloodstream. So the actual amount of domperidone that eventually makes it into baby’s bloodstream is trivial. Since there are so many reassuring long-term safety studies out there (granted on babies with GI symptoms) on babies getting much larger doses of domperidone directly, and achieving much higher blood levels, it is probably safe to conclude that if it is safe in higher concentrations among babies taking domperidone directly, it is more than likely safe for babies getting trivial amounts via breastfeeding.

    I don’t think any risk is acceptable absent a potential benefit. In other words, risks should only be considered acceptable when a patient deems the chance of benefit worth taking the risk.

    No one knows the definitive answer to your question as to why so many women out there cannot produce enough milk. I suspect, however, that a large part of the answer has to do with the ubiquitous availability and sophisticated marketing of formula and alternative feeding contraptions.

  • I’ve been on domperidone for a couple of weeks to increase my breastmilk and I am having chest pain and fast irregular heart beat. I was only taking 10that mg three times a day. I am not taking it anymore and hope these symptoms go away.

  • Meggie Ross

    Your Comments
    You mention ” Healthcare providers who practice lactation medicine should get together and critically review the literature pertaining to the use, efficacy, and risks of domperidone specifically in breastfeeding mothers. This process has been initiated.” Could you elaborate on what is being done and how Canadian Lactation Consultants can help?
    Many thanks, Meggie, IBCLC, PHN

  • Hi Maggie,

    Thanks for bringing this up. Your timing is pretty good. A consensus statement, jointly composed by 20+ breastfeeding experts in Canada, is just about ready for release -hopefully within a week. This will critically review the Health Canada-endorsed advisory, describe the standard of care among lactation medicine experts in Canada, and advocate for the sensible use of domperidone (when indicated) to support mothers struggling with breastfeeding. Canadian lactation consultants can help by sharing the consensus statement as broadly as possible. including LC’s, pharmacists, midwives, obstetricians, family docs, and pediatricians. Stay tuned… I’ll link to the statement from here.

  • I feel the issue at hand is really the mismanagement of breast feeding. Actual insufficient supply is very rare as most lactation professionals should be aware of. Our energy should be focussed on teaching mothers’ about breastfeeding, starting prenatally-not as part of their discharge teaching, after the hospital staff have been bottlefeeding babies throughout the hospital stay then sending moms home with a pump and telling them they better get some motilium…

  • What you’re saying is probably true. But there needs to be a multi-pronged approach to supporting breastfeeding. In addition to working towards improving the system, we also must have a practical approach to supporting moms who are struggling today. No doubt, far less domperidone would be needed if the system effectively supported breastfeeding for new moms. Until then, we must work with the reality we face. Besides, even if we get to the point where health centers fully and adequately support breastfeeding, there will still be moms who struggle. And for them, galactagogues will probably be part of the solution.

  • This is very reassuring to read. I can’t help but wonder- what about the possibilities for a drug that is specifically meant to increase breast-milk? If they know what it is in the domperidone that causes the increase of breast-milk, why can’t that be worked on to create a new drug for that sole purpose? I’m sure it would just cost too much. Sad.
    It is a miracle milk pill and I’m so happy I found it 🙂

  • I am wondering if I should stop taking domperidone? I am a type 1 diabetic who has had high cholesterol in the past. I am 33 years old. I take 4 pills 4 times daily of domperidone so that I can breastfeed my first child who is 4 months old. I was alerted to the concerns of domperidone by the pharmacist and that night felt like I could feel my heart beat in my chest while I was trying to go to sleep. Is this a coincidence due to the anxiety over this drug or am I experiencing heart palpitations? Should I be able to feel my heart beat in my chest (small thumping) or am I experiencing a reaction to domperidone and should stop this drug immediately? Help and thanks.

  • Hi Danny. Unfortunately, this blog cannot be a venue for giving medical advice. That said, the best I can do is recommend that you speak to your primary care practitioner as soon as possible, or alternatively to the physician who wrote you the prescription for domperidone in the first place. Either of those docs would be in a much better position than I to answer your question properly.

  • Yev

    I was prescribed DPD because I have low supply due to breast reduction surgery. I was diagnosed with arrhythmia some years back – a fact ignored by my dr. When after only a few days of taking 10ml 3 times a day I began to experience chest pains and palpitations and dizziness, I asked for ECG and halter monitor test. Both revealed abnormalities that were not there before. The dr then said that it is still safe for me to take the drug. In fact, that I can increase the dose to 30ml 3 times a day. I consulted two other doctors on this issue before feeling reasurred enough to continue. They all kept telling me that people who died are much older than me. And there are no reports of issues among women my age (34). After only two doses I experienced severe pain in my chest and dizziness. I stopped taking the drug, but it took over a week for the episodes of pain to decrease. After this I was still pressured by a lactation consultant and a doctor to continue. I was told that it’s likely my anxiety about taking this medication. I am amazed that no doctor wanted to take my concerns seriously. I feel like there’s a bias – a need to prove that the drug poses no real risk. To me it was clear that it does. And this risk has to be taken very seriously. I don’t know how this can be reported to health canada – but there are effects beyond theoretical on breastfeeding mothers. I am sure I am not the only one.

  • Celsus

    As a type 1 diabetic suffering from severe gastroparesis, I would simply starve to death if I had to stop taking domperidone, of which I need at least 60 mg. daily. What am I supposed to do if the drug is banned, resort to continual parenteral nutrition?