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2004
June
Article
United States Food and
Drug Administration Warning on Domperidone
Information from Anne
Kirkham, La Leche League Canada Professional Liaison Administrator
Canadian mothers may have questions concerning news that the US Food
and Drug Administration has issued a warning “Against Women
Using the Unapproved Drug, Domperidone, to Increase Milk
Production.” The FDA has also sent warning letters to several
American pharmacies that compound the drug and has told them to stop
preparing domperidone. (You can see this statement at www.fda.gov.) La Leche
League Canada (LLLC) is aware of the FDA warning and understands that
it does not apply to women, pharmacies or health practitioners in
Canada. This situation does not change any information or support
Leaders give to mothers in Canada.
Domperidone is approved in Canada, as a medication to modify upper
gastric motility. Use of domperidone for increasing milk supply,
through the drug side effect of increasing prolactin levels, is an
“off label use” of this medication in Canada.1
There is one Canadian study on the use of domperidone for milk
supply.1a
La Leche League International (LLLI) has issued a Hot Topic Statement
within the CBI section of their website, www.lalecheleague.org
and is discussing this event with Health Advisory Council (HAC)
members. LLLC expects to be informed as soon as results of discussions
with the HAC are available. Many health practitioners are responding to
the FDA announcement and are asking for
dialogue.2
When a true low milk supply exists and the usual strategies to increase
milk supply are not adequately effective, mothers may consider speaking
to their health practitioner about the use of prescription medications
or herbs. Information about these medical approaches as well as
conventional methods to increase milk supply are available to Leaders
in the Breastfeeding Answer Book (BAB), 3rd Ed3
Leaders may quote directly, naming the source as the BAB and always
quoting verbatim when speaking about medications from LLL or non-LLL
resources. As usual, Leaders never recommend, or advise against any
medication.
Some points to be aware of:
- The serious adverse reactions for domperidone
(Motilium®) quoted by the FDA are from IV (intravenous) use and the
medication used by breastfeeding mothers is an oral medication. The
case reports about IV use are not new, as the FDA warning suggests, but
are from two decades ago.4
- Following an oral dose of 10 mg, three times
daily, the average
concentration in breastmilk is 2.6 micrograms per litre of milk.5
- The American Academy of Pediatrics, in the
document The Transfer of
Drugs and other Chemicals Into Human Milk, Pediatrics 2001 says
domperidone is approved for use in the breastfeeding mother, regardless
of whether it is approved for use in the USA.6
- Domperidone is used in children for treating
gastric reflux.7
By far, most mothers will establish an adequate and abundant milk
supply while breastfeeding. The usual natural process of
“supply and demand” is the most important and
effective way that mothers produce plenty of milk. For some mothers,
the additional use of a medication prescribed by her doctor will make a
significant difference in providing her baby with mother’s
milk. Situations such as nursing an adopted baby or a very
premature baby are those that are more likely to benefit from this
medical approach. La Leche League Canada Leaders can answer
further questions about these topics.
1 For more information on “off label
use” of drugs, see http://aappolicy.aappublications.org/cgi/content/full/pediatrics;110/1/181
1a da Silva et
al. Effect of domperidone on milk production in mothers of
premature newborns: a randomized, double-blind, placebo-controlled
trial CMAJ
2001; 164(1): 17-21
2 http://neonatal.ama.ttuhsc.edu/lact/html/fda_warning_on_domperidone.html
3 Morbacher N and Stock J, The Breastfeeding Answer Book,
3rd rev. ed. 2003. P.168-171
4 Osbourne RJ, Slevin ML,
Hunter RW, Hamer J, Cardiac arrhythmias during cytotoxic chemotherapy:
role of domperidone. Hum
Toxicol 1985; 4: 617-626
5 Hofmeyr GJ et al,
Domperidone secretion in breastmilk and effect on puerperal prolactin
levels. Brit J Obs and
Gyn 1985;92:141-144.
6 http://aappolicy.aappublications.org/cgi/content/full/pediatrics%3b108/3/776
7 Bines JE,Quinlan JE,
Treves S, Kleinman RE, Winter HS. Efficacy of domperidone in infants
and children with gastroesophageal reflux. J Pediatr Gastroenterol Nutr.
1992 May; 14(4): 400-5.
Carroccio A,
Iacono G, Montalto G, Cavataio F, Soresi M, Notarbartolo A. Domperidone
plus magnesium hydroxide and aluminum hydroxide: a valid therapy in
children with gastroesophageal reflux. A double-blind randomized study
versus placebo. Scand J
Gastroenterol. 1994 Apr; 29(4):300-4.
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