The FDA and Domperidone

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As a paediatrician who treats only mothers and babies who are having difficulty with breastfeeding, I am very concerned about the warning about domperidone which was issued by the Federal Drug Administration in the US on June 7, 2004. It warns breastfeeding mothers about getting domperidone to enhance milk supply because it conceivably can cause cardiac arrhythmias.

 

What does the internet have to say about domperidone? If you write “domperidone” in your browser, you will come to the following “information” about domperidone.

 

Domperidone is a medicine that increases the movements or contractions of the stomach and bowel. Domperidone is also used to treat nausea and vomiting caused by other drugs used to treat Parkinson’s Disease. Domperidone is to be given only by or under the immediate supervision of your doctor.

 

The information, above, about what domperidone does, is accurate.

 

The first note is followed by the section on the internet that is called “People also ask” which, we believe, without proof, is where non-professionals (and professionals too, actually) would go first. This section “People also ask” seems always in the prominent second position. And the first question that comes up visible even if you have not clicked it yet, is:

 

“Why is domperidone banned in US? Answer: Domperidone has been banned in the United States for years because of fatal cardiac arrhythmias among cancer patients who had been prescribed the drug to prevent nausea and vomiting.”

 

Well, given the attitude of many health professionals “Better a live formula feeding mother than a dead breastfeeding mother”, plus the mother’s (or her family’s) reading of this response, it is not surprising that some of our patients have been ready, even enthusiastic, to start domperidone at the clinic, but decide not to take it after “doing research”. The only thing that people read and sticks in their mind is “fatal cardiac arrhythmias”.

 

What the answer does not clarify is that the decision in the US to “ban” domperidone is based on deaths in cancer patients (the answer mentions this) who were receiving extremely high doses of domperidone intravenously every few hours, typically a single intravenous domperidone dose that we would prescribe for an entire 24 hour day for a breastfeeding mother (the internet answer does not mention the extremely high doses the cancer patients were receiving). Furthermore, it needs to be emphasized that only about 13-17% of an oral dose of domperidone is actually absorbed by the person taking domperidone as compared to 100% of a dose given intravenously.

 

Thus, the situation of oral use of domperidone is not the same as large intravenous doses. Furthermore, many drugs used for treatment of cancer affect the cardiac rhythm, even in the absence of the patient receiving domperidone, and may cause cardiac arrest by decreasing or increasing the level of potassium in the blood.

 

Why didn’t they mention the danger of domperidone to diabetics, if they are so concerned? Some endocrinologists in the US are prescribing domperidone for gastric paresis for which it is a very good treatment? Why specifically for breastfeeding women? Why not specifically for diabetics who are at much greater risk of cardiac arrhythmias than women of reproductive age?

 

The fear of domperidone can sometimes cause bizarre recommendations. In at least one European country, it is considered okay by the medical society to take domperidone for gastric reflux, but not breastfeeding. Why is one permitted and not the other?

 

Why did this warning come out exactly on the day that the National Breastfeeding Campaign was to begin in the US?

 

I have used domperidone, in infants (for spitting up) but mostly to increase milk supply in women, in thousands of women, without any more than the occasional mother getting mild headaches or occasional menstrual irregularities or mild abdominal cramping as side effects. I cannot say the same for metoclopramide which I saw causing severe CNS side effects, aside from depression.

 

True, there is no such thing as a drug that never causes symptoms. Domperidone does seem to make migraine headaches more severe and occur more commonly in those who are prone to migraines.  But treatments for migraines are much more effective these days than they were a few years ago.

 

I have personally seen two children die of Stevens-Johnson Syndrome after taking Septra (cotrimoxazole). If I have seen two, how many have actually occurred in the US and Canada? Why no such warnings on Septra? I have, as a medical resident, seen at least one person die and several get severely ill after taking ASA, from gastric bleeding. In overdose, many children have died, and many have become seriously ill over the years because of ASA. Why no such warning on aspirin?

 

Many women have died and many more severely injured from taking the birth control pill. Why is it not banned?

 

The issue comes up about providing a drug for women in good health and that we should not be treating healthy women with a drug. In general, I agree. With all the talk about preventive medicine, when it actually comes down to trying to prevent illness, it is all lip service. The data are clear. Breastfeeding decreases the risk of breast cancer, ovarian cancer and type 2 diabetes in the mother.

 

In the baby it decreases the risk of diabetes (type 1 and 2), obesity, hypertension, high LDL/HDL levels, otitis media, asthma, and allergies, gastroenteritis, and in premature babies, necrotizing enterocolitis. The first 4 of these are all risk factors for atherosclerosis, the most significant degenerative disease in affluent societies and one of the biggest killer. The data are clear that breastfeeding results in better cognitive development in children. The data are less clear, but suggestive, that breastfeeding decreases the risk of certain cancers in children (Hodgkin’s and non Hodgkin’s lymphoma, breast cancer in later life), multiple sclerosis and inflammatory bowel disease.

 

Thus, we should do all that is reasonable to maintain and increase the success of woman who are breastfeeding. If this means that, in some cases, we use a drug that, in my experience of using it with thousands of women, is safe, with only minor side effects, we should have that option. Of course, there is no such thing as a drug which never causes side effects, and there are probably very few approved drugs (yes, even approved drugs) out there that have not killed someone, but if one weighs the risk against the benefits, domperidone can do much good. I will continue to prescribe domperidone to women when I feel it will be useful. It’s a shame, though, for women in the US to be deprived of this drug. The FDA says that it will monitor the border to make sure none gets through. Good for them. With heroine and cocaine getting through their borders as through a sieve, it is a great relief that the US can now be sure that their borders are safe against an influx of the dreaded domperidone. What a waste of manpower! What a waste!

 

The information presented here is general and not a substitute for personalized treatment from an International Board Certified Lactation Consultant (IBCLC) or other qualified medical professionals.

 

This information sheet may be copied and distributed without further permission on the condition that it is not used in any context that violates the WHO International Code on the Marketing of Breastmilk Substitutes (1981) and subsequent World Health Assembly resolutions. If you don’t know what this means, please email us to ask!

 

©IBC, February 2009, 2021

 

Questions or concerns?  Email Dr. Jack Newman (read the page carefully, and answer the listed questions).

 

Make an appointment at the Newman Breastfeeding Clinic.