The FDA's ombudsman's response to non physicians who have written about domperidone has not been satisfactory. At least not the ones I have been forwarded. He is dismissive and suggests that there is real danger to the baby, getting it through the milk, an absurdity if ever there was one. If you are an American, write your congressman/senator about this insane step the FDA has taken, and get your patients who are on domperidone to do the same.

Here, below, is my take on this question.

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.

The FDA has basically come up with a political statement. They seem ticked off because people were going around their recommendations. The deaths (and I believe there were two) occurred with intravenous domperidone, which is never used any more and has never been used for enhancing milk supply. It is likely that if this drug was given intravenously, that the patients were sick with other problems as well, a confounding variable. Furthermore, unlike what the FDA has led people to believe, perhaps unintentionally, these are not new cases, but 2 decades old.

Why didn't they mention metoclopramide in their warning, which is far more dangerous (it can cause severe depression in oral doses, which domperidone does not), and is also being used off label to increase milk supply, but which, on the other hand is available and approved for gastric motility problems in the US? Can it be that they are not concerned about the danger but rather the threat to their authority?

Why didn't they mention the danger to diabetics, if they are so concerned, for whom some endocrinologists in the US are prescribing domperidone for gastric paresis? Why specifically for breastfeeding women? Why not specifically for diabetics who are at much greater risk of cardiac arrhythmias than women of reproductive age?

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, probably well over 1000 women, without any more than mild headache, occasional menstrual irregularities and mild abdominal cramping as side effects. I cannot say the same for metoclopramide which I saw causing severe CNS side effects, aside from depression.

I have personally seen two children die of Stevens-Johnson Syndrome after taking Septra. 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?

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. I disagree. 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 in the mother. It decreases the risk of diabetes (type I and II), obesity, hypertension, high LDL/HDL levels, otitis media, asthma, and allergies, gastroenteritis, and 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 the biggest killer. The data are fairly 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 well over 1000 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 haven't 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 like a sieve, it's great 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!

Jack Newman, MD, FRCPC