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 women 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!
First written in June 2004 by Jack Newman, MD, FRCPC
Revised February 2009
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