Domperidone

Domperidone can be very useful to increase the mother’s milk supply and, more importantly, milk flow from the mother to the baby.

 

An important point: If all mothers had the best start with breastfeeding, from the very start, having as few interventions as is reasonable during labour and birth and received good help from the beginning, most mothers taking domperidone would not have needed it.

 

In our clinic, we use domperidone for several reasons in addition to the situation when the baby is not getting enough milk from the breast and in mothers who are already supplementing with formula and with bottles.

 

Help with breastfeeding

 

For example, we sometimes use domperidone also when the baby is not latching on even if the mother is able to produce all the baby needs, because increased milk production results, usually, in an increased milk flow and if there is increased milk flow the baby is more likely to latch on. A baby’s beginning to latch on largely depends on milk flow from the breast.

 

We use it sometimes also when the mother has sore nipples because when the flow of milk is slow, a baby tends to slip down on to the nipple causing more pain and some babies will pull at the breast when the flow of milk is slow.  As well, more milk means the baby will spend less time on the breast and will stay full longer with the result that the mother will get a longer break with the baby more satisfied.

 

We use it frequently when the mother has had late onset decreased milk supply. “Decreased milk supply does not necessarily mean “not enough milk”.  Mothers who have had late onset decreased milk supply usually started out with an abundant milk supply, so “decreased” can still mean the baby is getting enough.  However, the baby’s behaviour shows that he is not happy with the flow of milk.

 

Late onset decreased milk supply is often, but by no means always, due to the baby’s having a tongue tie. Releasing a tongue tie when the milk flow has decreased sometimes results in the baby refusing the breast and we prefer increasing the milk supply and flow first and then, a week or so later, releasing the tongue tie in this situation. There are other reasons for late onset decreased milk supply, such as feeding one breast at a feeding without offering the other, starting hormonal birth control, including intrauterine devices that release progestins, etc.

 

How does domperidone work?

 

Domperidone works by blocking dopamine at the level of the pituitary gland so that prolactin secretion by the pituitary gland is increased (dopamine inhibits the release of prolactin). Many people seem to worry about blocking dopamine and what effect it may have on the functions of dopamine on mood; however, domperidone acts peripherally, outside the brain. According to Thomas Hale (author of Medications and Mothers’ Milk) in a letter to the European Medications Agency, “Due to its unique structure, domperidone has very limited penetration of the blood-brain barrier. The central/peripheral ratio for domperidone is approximately 1:300, compared with 1:45 for metoclopramide, a similar drug. This, in practice, means a very low incidence of CNS side effects in patients.” In other words, domperidone barely enters into the brain (does not pass the blood-brain barrier, the pituitary being “functionally” outside the blood brain-barrier).

 

By increasing the prolactin secretion from the pituitary, domperidone increases milk production and increases milk flow to the baby.  And babies learn to breastfeed by breastfeeding. In other words, by getting milk from the breast (another reason to use the lactation aid at the breast, incidentally).

 

But domperidone must not be used in isolation. It is also important to improve the baby’s latch and also use breast compression to increase the flow of milk to the baby.  And to make sure the baby is fed on both breasts at each feeding. And if supplementation is required, using a lactation aid at the breast works better than any type of supplementation away from the breast (bottle, cup, finger feeding, nipple shield). Domperidone is important while at the same time not the only approach to the baby not getting enough milk from the breast.

 

Does domperidone work for everyone?

 

No drug works for everyone in every situation or in the same way for different people, whether it be a drug for high blood pressure, an antibiotic to treat pneumonia, or any drug for any problem.  In this, domperidone is not different from other drugs.

 

But there are ways to improve the likelihood that domperidone will work.  A major problem interfering with domperidone’s action is the use of bottles to supplement the baby.  Bottles interfere with how a baby latches on and thus decreases the effect of domperidone.  Improving the latch and using breast compression are helpful to get the better results from domperidone. Using a lactation aid at the breast to supplement instead of a bottle also increases the likelihood that domperidone will work better.  In other words, domperidone is not a magic bullet and is only part of the approach to increasing milk intake by the baby.

 

Is domperidone safe?

 

In fact, domperidone is one of the safer medications around.  True, there is no such thing as a drug that has no side effects, and domperidone has some as well.  As Hale has written in the same document as above: “At a minimum, more than a billion doses have been used in Europe alone and many more world-wide, in perhaps millions of patients”.

 

“…Domperidone has an excellent safety profile and is generally very well tolerated.”

 

A recent study in our clinic, done on the records of 1000 mothers and their babies by the department of clinical pharmacology of the Hospital for Sick Children, showed very few side effects.  The most common (in 10% of mothers) was mild and transient headache. Also reported, but not seen in this study, is weight gain in about 10% of mothers.  Incidentally, this study suggested that the use of domperidone increased the mother’s production of milk by 28%. To be honest, I’m not sure how they came to this conclusion, but I think it is not unreasonable, unlike statements by people who say that the use of domperidone has only a very minimal effect on milk supply.  People who don’t work “hands on” helping breastfeeding mothers and their babies, I should add.  Other studies have shown an increase in milk production by the mother of up to 96%.

 

The warnings (in 2012 and 2015) by Health Canada are not based on good evidence and there is no good evidence at all that there is a risk from any cardiac side effect with domperidone. (In fact, it is not a Health Canada warning at all, but rather an endorsed warning which originates from a company that makes domperidone, covering their liability). It is bizarre that the fax sent out by Health Canada in January 2015 does not mention any references though apparently this is not rare for Health Canada.  Even someone who has a prolonged QT interval, well, in theory there is a risk, but in practical terms there is not.

 

Health Canada’s warning is a word for word repetition of the statement by the European Medications Agency which gets many of its ideas from the drug manufacturers and formula companies.  In spite of several deaths in Europe in mothers taking the birth control pill (and in Canada too: 23 deaths in 8 years in Canada as reported by Health Canada a few years ago), everyone seems to agree that the birth control pill is worth the risk.  Well, considering there are methods of contraception other than the birth control pill, including the lactation amenorrhea method (LAM) in breastfeeding mothers, I would dispute that.  But of course, the birth control pill is very much popular with physicians and other health professionals and pharmaceutical companies make a lot of money on the birth control pill, which is not the case with domperidone.  We checked with Health Canada in 2012 when all this started about domperidone in Canada.  Health Canada has never had a report of an unexpected death in a breastfeeding woman taking domperidone.  We checked again after the January 2015 warning.  No reports of any deaths in the age group of mothers breastfeeding.  In fact, they have not had any reports of any significant side effects that can definitely be attributed to domperidone in patients of any age.

 

Furthermore, I personally have treated many thousands of mothers with domperidone in much larger doses than Health Canada’s recommended maximum dose and have recommended it for many more who then received a prescription from their own family doctor.  Very few mothers had any side effects at all and those who did had very minor ones that disappeared within days.

 

Here is an editorial in the British Medical Journal about an increased risk of venous thromboembolism (potentially fatal) with the birth control pill.

 

Here is the difference between domperidone and the birth control pill:  When a study finds that birth control pills cause a much higher rate of venous thromboembolism (as discussed in this editorial), one only needs to scroll down on the commentary to read the following:

 

“These results … provide important guidance for the safe prescribing of oral contraceptives.”

 

What does this mean?  We can use birth control pills without worry because the benefit outweighs the risk.  On the other hand, we can’t use domperidone because improving breastfeeding success is not important.

 

There are so many much more dangerous drugs out there than domperidone. The same worries about a prolonged QT interval could be voiced about many drugs that are used daily, including some antibiotics, but the current discussion seems to single out domperidone only. Why would that be? Again, because improving breastfeeding is of no real importance, since we have such wonderful breastmilk substitutes; NOT.

 

Indeed, metoclopramide which is commonly used in the US instead of domperidone to increase milk supply has been associated with permanent neurological dysfunction and has been getting none of the negative publicity in spite of a black box warning on metoclopramide by the Federal Drug Administration.

 

And what about acetaminophen? You know, that stuff that parents give to their children every time they have a fever or an ache and a pain? Read the article on the Huffington Post and this, in the article: “Acetaminophen overdose sends as many as 78,000 Americans to the emergency room annually and results in 33,000 hospitalizations a year, federal data shows. Acetaminophen is also the nation’s leading cause of acute liver failure, according to data from an ongoing study funded by the National Institutes for Health.”

 

So, what is all this fuss about domperidone?

 

Exactly, what is all the fuss about?

 

I receive emails from mothers who say that, according to their doctor, they cannot take domperidone because they had a murmur when they were children or because their grandfather had a heart attack or because they had an operation for a hole in the heart when they were babies or because they occasionally have palpitations and other completely irrelevant issues.  The only reason for concern is if the mother has a prolonged QT interval on electrocardiogram and this problem is very uncommon if not rare in a population of women of reproductive age.  This one uncommon indication has been widened to include every possible heart problem that one can imagine.

 

The situation is bizarre.  A mother going to the pharmacy with a prescription for domperidone may be asked for what reason she will be taking domperidone.  If she answers, “for increasing my milk supply”, she will be told in many pharmacies that her prescription for domperidone cannot be filled.  If she answers, “for gastric problems”, she will be told, “Oh, your prescription will be ready in 15 to 20 minutes. We will call you on this beeper when it’s ready.”

 

That’s it! According to the strange thinking of the European Medications Agency and the copycat thinking of Health Canada, domperidone is dangerous only if you are taking it to improve breastfeeding, but not to deal with gastric problems.

 

But, here is a secret.  The European Medications Agency’s own studies showed no effect on QT interval in healthy volunteers.

 

After all is said and done, if you have unexplained palpitations or a significant family history of unexpected cardiac arrest, have an electrocardiogram, with special attention to a prolonged QT interval, before starting the domperidone.

 

What is the dose of domperidone?

 

We start with a dose of 30 mg (3 tablets, as the only available size of a tablet is 10 mg) of domperidone 3 times a day.  We then might increase the dose in two steps, if the response to the lower dose is not as good as it could be, first to 40 (4 tablets) 3 times a day and then 16 tablets a day, divided into three doses (6 tablets, 5 tablets, 5 tablets).

 

The reason for going up in 3 steps is basically to find the lowest dose that actually works, taking into consideration that the higher the dose of any drug, the more likely there will be side effects.

 

On the recommendation of Health Canada, mothers are often treated with only 10 mg (1 tablet) 3 times a day.  A small number of mothers do seem to get an effect from this tiny dose, but I believe that helping the mother improve the breastfeeding with a better latch and using breast compression would have prevented the “need” for domperidone in mothers who respond to 10 mg three times a day. Furthermore, it is strange to worry about a drug but then prescribe an inadequate, usually useless, dose.

 

How long should the mother take the domperidone?

 

We now encourage mothers to keep taking the domperidone until the baby is well established on solids).  That way, if the milk supply decreases when the mother decreases the dose of domperidone, the baby can make up the extra calories and nutrients he needs by eating more food until the dose of domperidone can be bumped up again.

 

But this is not always necessary by any means.  If the domperidone is used to increase the flow so that the baby who is not latching on is encouraged to latch on, then once the baby is latched on and drinking well, the mother can wean off the domperidone (more quickly than as described below), as a baby well latched on can get more milk from the breast than a pump.

 

How to wean off the domperidone

 

We generally recommend dropping 1 pill per day a week, always on the same day of the week, so if the mother is taking 12 pills a day now, next week, she will take 11 pills a day for a week, then one week later 10 pills etc.

 

The reason for slowly weaning off the domperidone is that there are reports that rapid weaning off the domperidone after the mother has been taking it for several months may lead to symptoms of anxiety, sleeplessness and depression in the mother.  This has not been a common problem amongst our patients, as they tend to follow our approach of slow weaning off the domperidone.

 

Is this syndrome of anxiety due somehow to domperidone?  Not really.  Probably it is due to rapid decrease in the prolactin levels, which are also seen in mothers who stop breastfeeding “cold turkey” and also mothers who are treated with drugs such as cabergoline which decrease prolactin levels.

 

What people often ask about is the effect on the baby.

 

As with almost all medications, the amount of domperidone that enters the milk is minuscule and very unlikely to cause any problems for the baby. If the mother is taking 80 mg of domperidone a day, the amount the baby would get in the milk is 0.007 micrograms (nothing to do with James Bond), an insignificant, minuscule dose.  Furthermore, domperidone actually is not well absorbed from the stomach and intestinal tract, and only about 15% of the ingested dose is actually absorbed.  So, side effects or harm to the baby is vanishingly small, in fact zero.

 

Anything else?

 

It has been suggested that domperidone only releases stored prolactin from the pituitary gland and once the prolactin has been released, the effect of domperidone wears off.  We do see in some of our patients who get an initial good response to domperidone, but it does not last and declines after 3 or 4 days to a week. But the explanation of depletion of prolactin from the pituitary just does not make sense.

 

First of all, because it certainly does seem to occur, but only in a very small minority of mothers.

 

Secondly, because when this does occur, increasing the dose of domperidone will overcome this decline in the effect of the domperidone.  Thus, some prolactin is left in the pituitary??

 

What’s the explanation?  I don’t know.

 

Need help with breastfeeding? Make an appointment with our clinic

 

Copyright: Jack Newman, MD, FRCPC, 2017, 2018

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