On the FDA and Domperidone
As a paediatrician who deals now only with 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.
The FDA has basically come up with a political statement. They seem
really bothered because people were going around using a drug which
they have not approved. 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. Domperidone was given intravenously in huge
doses to patients who were sick with other problems as well, notably
cancer for which they were getting chemotherapy. Domperidone was being
used to decrease nausea and vomiting. Some patients were getting 1000
mg of domperidone every 4 hours intravenously, compared to our usual
dose of 30 mg 3 times a day, taken by mouth. It is also likely that
some of the chemotherapy drugs the patients would have received have
cardiac side effects (for example, doxorubicin) and it was the
combination of the huge doses of domperidone intravenously plus other
drugs that caused the problem. 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 in the US, 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? Here is part of a letter I received about
metoclopramide and domperidone as a result of this to do about
domperidone. “...my mother...is on domperidone for gastroparesis. She's
5 feet tall, and lost over 20 lbs...down to 82 lbs. And why is she on
domperidone? Because she had depression and SEVERE panic attacks with
the Reglan (metoclopramide). She was in and out of the senior psych
ward all last spring. So my folks get domperidone from outside the US.”
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, 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.
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?
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. 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 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 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
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 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 their borders as through 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!
Questions? First look at the website nbci.ca or drjacknewman.com. If the information you need is not there, go to Contact Us and give us the information listed there in your email. Information is also available in Dr. Jack Newman’s Guide to Breastfeeding (called The Ultimate Breastfeeding Book of Answers in the USA); and/or our DVD, Dr. Jack Newman’s Visual Guide to Breastfeeding (available in French or with subtitles in Spanish, Portuguese and Italian); and/or The Latch Book and Other Keys to Breastfeeding Success; and/or L-eat Latch and Transfer Tool; and/or the GamePlan for Protecting and Supporting Breastfeeding in the First 24 Hours of Life and Beyond.
To make an appointment online with our clinic please visit www.nbci.ca. If you do not have easy access to email or internet, you may phone (416) 498-0002.
First written in June 2004 by Jack Newman, MD, FRCPC
Revised February 2009