http://www.fda.gov/bbs/topics/ANSWERS/2004/ANS01292.html


FDA Talk Paper

T04-17
June 7, 2004

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA




FDA Warns Against Women Using Unapproved Drug, Domperidone, to Increase
Milk Production

In response to reports that women may be using an unapproved drug,
domperidone, to increase milk production (lactation), the Food and Drug
Administration (FDA) is warning breastfeeding women not to use this product
because of safety concerns. Today, FDA also issued six letters to
pharmacies that compound products containing domperidone and firms that
supply domperidone for use in compounding.

The Agency also is issuing an Import Alert which alerts FDA field personnel
to be on the lookout for attempts to import this drug so that it can be
detained and refused admission into the U.S. if appropriate.

FDA took these actions because it has become aware that some women who
breastfeed and/or pump breast milk are purchasing this drug, domperidone,
from compounding pharmacies and from sources in foreign countries to
increase breast milk production. Domperidone may increase the secretion of
prolactin, a hormone that is needed for lactation.

Although domperidone is approved in several countries outside the U.S. to
treat certain gastric disorders, it is not approved in any country,
including the U.S., for enhancing breast milk production in lactating women
and is also not approved in the U.S. for any indication.

The agency is concerned with the potential public health risks associated
with domperidone. There have been several published reports and case
studies of cardiac arrhythmias, cardiac arrest, and sudden death in
patients receiving an intravenous form of domperidone that has been
withdrawn from marketing in a number of countries. In several countries
where the oral form of domperidone continues to be marketed, labels for the
product contain specific warnings against use of domperidone by
breastfeeding women and note that the drug is excreted in breast milk that
could expose a breastfeeding infant to unknown risks. Because of the
possibility of serious adverse effects, FDA recommends that breastfeeding
women not use domperidone to increase milk production.

The FDA recognizes the immense health benefits that breast milk provides
for a nursing infant and is taking these actions today not to discourage
women from breastfeeding but rather to warn them not to use this particular
drug while they are breastfeeding.

The letters issued by FDA today stated that all drug products containing
domperidone (whether compounded or not) violate the Federal Food, Drug, and
Cosmetic Act (the Act) because they are unapproved new drugs and
misbranded. In addition, distribution within the U.S., or importation of
domperidone-containing products, violates the law. FDA informed the warning
letter recipients that further violations of the Act may result in
enforcement actions including seizure and injunction.

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