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Domperidone 

Domperidone (Motilium™) is a drug that has, as a side effect, the increase of milk production, probably by increasing prolactin production by the pituitary gland. Prolactin is the hormone that stimulates the cells in the mother's breast to produce milk. Domperidone increases prolactin secretion indirectly, by interfering with the action of dopamine, whose action is to decrease the secretion of prolactin by the pituitary gland. Domperidone is generally used for disorders of the gastrointestinal tract (gut) and has not been released in Canada for use as a stimulant for milk production. This does not mean that it cannot be prescribed for this reason, but rather that the manufacturer does not back its use for increasing milk production. However, there are several studies that show that it works to increase milk production and that it is a relatively safe drug. It has been used, for several years, in small infants who spit up and lose weight, but was replaced until a few years ago by cisapride (Prepulsid™) (cisapride has since been taken off the market because it can cause serious cardiac problems). Domperidone is not in the same family of medication as cisapride. Another, related, but older medication, metoclopramide (Maxeran™, Reglan™), is also known to increase milk production, but it has frequent side effects which have made its use for many breastfeeding mothers unacceptable (fatigue, irritability, depression). Domperidone has many fewer side effects because it does not enter the brain tissue in significant amounts (does not pass the blood-brain barrier).

In June of 2004, the Federal Drug Administration (FDA) in the US put out a warning against using domperidone because of possible cardiac side effects. This unfortunate step was taken without considering the fact that the cardiac side effects occurred only when the drug was given intravenously to otherwise very sick patients. In all the years I have used domperidone in so many mothers, I have not yet heard of any significant cardiac side effects that could be definitely attributed to domperidone. Incidentally, the Federal Drug Administration has no authority outside the US, and even in the US, compounding pharmacies, which are not regulated by the FDA, are continuing to provide patients with domperidone. See the information sheet On the FDA and Domperidone.

When is it appropriate to use domperidone?

Domperidone must never be used as the first approach to correcting breastfeeding difficulties. Domperidone is not a cure for all things. It should be used only in conjunction with fixing all other factors that may result in insufficient milk supply. (See the information sheet Protocol for Managing Breastmilk Intake as well as the video clips). What can be done?

Do as much skin to skin as possible with the baby, during and in between feedings. See information sheet: The Importance of Skin to Skin Contact.
Correct the baby's latch so that the baby can best obtain the milk the mother has available. Correcting the latch may be all that is necessary to change a situation of "not enough milk" to one of "plenty of milk" (Also see the video clips on our website).
Use breast compressions to increase the intake of milk (See information sheet Breast Compression).
If you are breastfeeding exclusively, try expressing your milk after the feedings. A few minutes of hand expression after the feedings may be very effective to increase the milk supply. Some mothers may wish to use a hospital grade pump for 10-15 minutes after feedings—this may be very effective for some and not at all for others. Do what you can. A mother exhausted from pumping is probably no further ahead with milk production. And yes, it is not necessary to express your milk if this is a burden and makes you want to stop altogether.
Correct sucking problems, stopping the use of artificial nipples

Using Domperidone for Increasing Milk Production:

Domperidone works particularly well to increase milk production under the following circumstances:
It has frequently been noted that a mother who is pumping milk for a sick or premature baby in hospital has a decrease in the amount she pumps around four or five weeks after the baby is born. The reasons for this decrease are likely many (not putting the baby to the breast early enough, no true kangaroo mother care, etc), but domperidone generally brings the amount of milk pumped back to where it was or even to higher levels.
When a mother has a decrease in milk supply, often associated with the use of birth control pills. Avoid estrogen containing, or even progesterone only birth control pills or progesterone releasing intrauterine devices (Mirena) while breastfeeding. See the information sheet, Slow Weight Gain Following Early Good Weight Gain for other reasons milk supply might decrease and fix what can be fixed.
Domperidone still works, but often less dramatically when:
The mother is pumping for a sick or premature baby but has not managed to develop a full milk supply.
The mother is trying to develop a full milk supply while breastfeeding an adopted baby.
The mother is trying to wean the baby from supplements.

Side Effects of Domperidone:

As with all medications, side effects are possible, and many have been reported with domperidone (textbooks often list any side effect ever reported, but symptoms reported are not necessarily due to the drug a person is taking). There is no such thing as a 100% safe drug. However, our clinical experience has been that side effects in the mother are extremely uncommon, except for increasing milk supply. Some side effects which mothers we have treated have reported (very uncommonly, incidentally):headache which disappeared after a few days or when the dose was reduced (probably the most common side effect)
abdominal cramps
dry mouth
alteration of menstrual periods, usually stopping them, but also breakthrough bleeding is possible. It is usual when breastfeeding not to have menstrual periods for many months
a very few mothers who have taken domperidone for many months, usually more than a year, have reported feelings of anxiety, sleeplessness, loss of appetite and other symptoms when they stopped the domperidone “cold turkey”.

The amount that gets into the milk is so tiny that side effects in the baby should not be expected. Mothers have not reported any to us, in many years of use, at least not symptoms that can be attributed definitely to the domperidone. Certainly the amount the baby gets through the milk is a tiny percentage of what babies would get if being treated for spitting up. Remember, this is a medication often given to babies for reflux.

Are There Long Term Concerns About The Use of Domperidone?

The manufacturer states in its literature that chronic treatment with domperidone in rodents has resulted in increased numbers of breast tumours in the rodents. The literature goes on to state that this has never been documented in humans. Note that toxicity studies of medication usually require treatment with huge doses over periods of time involving most or all of the animal's lifetime. Note also that not breastfeeding increases the risk of breast cancer, and breast cancer risk decreases the longer you breastfeed. Also note, in Canada we have used Domperidone as a ‘milk-making’ medication for over 20 years

Using Domperidone:

Generally, we now start domperidone at 30 mg (three 10 mg tablets) 3 times a day. In some situations we go as high as 40 mg 4 times a day. Printouts from the pharmacy often suggest taking domperidone 30 minutes before eating, but that is because of its use for digestive intolerance. It is true, though, that absorption of domperidone is greater on an empty stomach. You can take the domperidone about every 8 hours, 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). Many mothers take the domperidone for 3 to 8 weeks, but sometimes it is needed longer than that, and sometimes it is impossible for mothers to maintain their milk supply without staying on domperidone. Mothers who are breastfeeding adopted babies may have to take the drug much longer. People taking domperidone for stomach disorders often have been taking it for many years.

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.

Domperidone, Stopping

When domperidone was being used for babies (and now that cisapride is off the market, it is being used again), it was common for the babies to be on the medication for several months, even longer. Since the amount of domperidone that gets into the milk is very small indeed, from the baby’s point of view, there should be no issue in the mother taking it to increase milk supply for several months. Our experience with this drug is that short-term side effects are very few and almost always very mild. Worldwide experience with domperidone over at least two decades suggests that long-term side effects also are rare. Some of the mothers in our clinic, breastfeeding adopted babies, have been on the medication for 18 months without any apparent side effects. Patients using domperidone for stomach disorders may be on it for many years. We hope you won’t need domperidone for very long, but if it’s necessary and helpful, stay on it
How long does it take for domperidone to work?

It depends on the situation. In a situation where the mother had had a good milk supply, but it decreased for some reason (e.g. going on the birth control pill, see the information sheet Slow Weight Following Early Good Weight Gain), domperidone often works very rapidly to increase the milk supply. Often, within a day or two the mother is seeing a difference (and so does her baby). But this is not always so, and in many situations, it may take a week or more for the mother to start getting an effect. On occasion, we have had mothers only starting to get an increase in their milk supplies a month or more after starting to take it. Therefore, we generally recommended that the mother take the domperidone for at least six weeks in order to be sure whether it has worked or not.

It is our impression that domperidone works best after the first few weeks after the mother has given birth (usually after about four weeks). This has not been proved, but there are theoretical reasons why it may be so. For this reason, we have often waited to prescribe it until the baby is at least three weeks, mainly because we did not want the mother to become discouraged if she did not see any rapid increase in her milk supply. If you keep this in mind, taking domperidone before three or four weeks after the birth of the baby is worth a try because sometimes it does work very well early on.

How do I know how long to take domperidone?

Usually, we ask the mother take it for at least two weeks at a minimum and then re-evaluate the situation. There are several possibilities.

The milk supply has increased substantially, to the point where there is no longer a consideration of using supplements, or the mother has been able to stop supplements with the baby continuing to gain well on breastfeeding alone.
The milk supply has increased to a point that the mother feels is satisfactory. For example, she may still need to supplement, but the baby does not fuss any more at the breast and drinks contentedly.
There has been little or no effect with the Protocol to Manage Breastmilk Intake and the domperidone. Often waiting or increasing the dose may help.
The 
In the first situation (but not necessarily always in that situation), we may suggest the mother start weaning herself from the domperidone in this way:

When you are ready to start weaning from the domperidone, drop one pill, so that now, instead of nine pills a day, you will be taking eight.
Wait four or five days, a week if you wish. If you see no change in your milk supply, drop another pill.
Wait another four or five days. If you see no change in your milk supply, drop another pill.
Continue in this way until you are down to no pills a day. If there has been no decrease in your milk supply, or if there has been a small decrease that does not affect the breastfeeding and baby’s weight gain, that’s just what we hope to have happened, and many mothers manage this.
If, however, your supply diminishes significantly, return to the previous effective dose and do not drop any pills for a couple of weeks at least.
If you are keen to go off the domperidone, after a couple of weeks on the same dose, start dropping a pill a day, as in step 1 above. Some mothers, who were not able to get off the domperidone with steps 1-4 above the first time, can do it the second or the third time.
You may find that you have to continue a certain dose to maintain your milk supply. But following steps 1-4 above will get you to the lowest effective dose.

It is possible, however, that after two weeks of taking domperidone, you are not where you want to be. In that case, you should continue using the domperidone. If you are still not where you want to be after two to six weeks of domperidone, it is time to think some more about the domperidone. If you are supplementing, and have managed to reduce the amount of supplement from 400 ml to 300 ml (14 ounces to 10 ounces), is it really worth taking a drug in order to do this? I would say yes, but this is up to you. If you feel it is, then continue with the domperidone, but try weaning the number of pills down to minimum number that maintain your milk supply, as above. If you do not feel it is worth it, try weaning down as above, and if you don’t see any change once you get to no pills a day, fine. However, if you do notice a real change in the milk supply as you lower the dose, maybe the domperidone is more effective than you had thought (remember, after several weeks, your baby is significantly heavier, and it may be that instead of needing 400 ml (14 ounces) without domperidone, the baby might actually need 20 ounces to maintain good weight gain, in which case the domperidone is actually doing something).
Remember: Before using domperidone, the breastfeeding should be fixed, and as quickly as possible. This means:

Getting the best latch possible. This alone may result in the baby getting enough milk.
Using compressions to increase milk intake by the baby.
“Finish” one side before offering the other (see Protocol to Manage Breastmilk Intake) for an explanation on how to know the baby is getting milk and the video clips on our website) to help you identify good drinking.
Do not limit the baby to one side if the baby is not getting enough. Switch to the other side once the baby is no longer getting milk even with the compressions.
Switch back and forth, as long as the baby is getting good amounts of milk.
Follow the Protocol to Manage Breastmilk Intake