Here is my letter to the pharmacies listed with the June 7 "FDA Talk Paper"
at http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01292.html:

Pharmacists:

It has come to my attention that you have been issued a warning letter by
the Food and Drug Administration regarding your supplying or compounding of
domperidone, a medication which until now has been in something of a legal
“no man’s land” in the United States.  I am writing to urge you not to cease
furnishing this medication to American consumers.  The FDA warning at
http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01292.html shows a gross
misunderstanding and/or disregard of the relative risks and benefits of
domperidone use for promoting lactation.

The FDA warning mentions reports of cardiac symptoms and death from
intravenous administration of domperidone.   Noted lactation pharmacologist
Thomas Hale has immediately alerted his colleagues to the dosages involved
in these reports, which represent plasma levels some two orders of magnitude
greater than those resulting from typical oral doses of domperidone for
promoting lactation:
http://neonatal.ama.ttuhsc.edu/lact/html/fda_warning_on_domperidone.html
The FDA warning fails to note that oral domperidone is in use in several
countries for infant gastric reflux symptoms.

To characterize the use of domperidone for promoting lactation as a hazard
presumes that its alternatives are safe and effective.  The commonly used
alternative, metoclopramide, has serious side effects, some of which can be
particularly dangerous in a postpartum depression context:
 http://www.fda.gov/cder/foi/label/2001/18821s20lbl.pdf

The alternative to breastfeeding, artificial feeding of infants, has many
risks.  Here is a link to one compilation of journal articles on the risks
of artificial feeding:
http://www.geocities.com/4birthing/risks.htm

The references I have mentioned quantify the risks of domperidone and of its
alternatives.  Just as important, though impossible to quantify, are the
benefits of NORMAL FAMILY PHYSIOLOGICAL FUNCTION.  Viagra, for example, has
given many husbands new hope for normal marital relations.  I have seen many
testimonies from mothers that domperidone has made a significant difference
in their ability to lactate for their infants, whether they are dealing with
adoption, breast reduction, prematurity, or other complicated lactation
situations.  To tell these mothers that formula will do just fine
trivializes their resolve to have a normal maternal relationship with and to
provide nature’s best for their infants.

Babies grow and wean, so domperidone use is relatively short-term, but the
tender memories of the nursing relationship, the health benefits to the
child, and the patterns of responsive mothering that are established endure.
Domperidone, as mentioned in The Breastfeeding Answer Book (La Leche League,
Schaumburg, IL, 2003) and other recent publications, has effectively become
the “standard of practice” for many lactation professionals seeking to aid
mothers who need to boost milk supply.  I suspect that a “Domperidone
Defense Fund” could coalesce just as quickly as a “Viagra Defense Fund”
would if the exercise of doctor and patient discretion about Viagra’s risks
and benefits were threatened.  Please do not hesitate to contact me if you
want help to get in touch with others who are dismayed by this FDA warning
against domperidone.

Earnestly,
Ruth Marie Piatak, B.A., M.S., La Leche League Leader

cc:
Lactnet lactation professionals’ email list
La Leche League of Dallas email list
La Leche League of Texas email list
San Diego County Breastfeeding Coalition
The Honorable Tommy G. Thompson, Secretary, Health and Human Services
Paul Burg, President, Spectrum Chemicals & Laboratory Products
Gene Ragazzo, R.Ph. and James Palmieri, R.Ph., Owners, Drugs Are Us, Inc.
Douglas I. Ellsworth, Director, New Jersey District, FDA
Stephen R. Caudle, Owner, Line Avenue Pharmacy
H. Tyler Thornburg, Director, New Orleans District, FDA
James Peter Sumerville, President, Axium Healthcare Pharmacy
Emma R. Singleton, Director, Florida District, FDA
Bill Swail, President, Peoples Pharmacy, Inc.
Michael A. Chappell, Director, Dallas District, FDA
Martin & Jones, Trial Lawyers

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