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receiving an intravenous form of domperidone that has been withdrawn from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.

+++++++++++++++++++++++++++++++++==

 

FDA ALERT - Risks of Use in Labor and Delivery   

This Patient Information Sheet is for pregnant women who may receive
misoprostol to soften their cervix or induce contractions to begin labor.
Misoprostol is sometimes used to decrease blood loss after delivery of a
baby. These uses are not approved by the FDA. No company has sent the FDA
scientific proof that misoprostol is safe and effective for these uses. 

There can be serious side effects, including a torn uterus (womb), when
misoprostol is used for labor and delivery. A torn uterus may result in
severe bleeding, having the uterus removed (hysterectomy), and death of the
mother or baby. These side effects are more likely in women who have had
previous uterine surgery, a previous Cesarean delivery (C-section), or
several previous births. 

This information reflects FDA's preliminary analysis of data concerning this
drug. FDA is considering, but has not reached a final conclusion about, this
information. FDA intends to update this sheet when additional information or
analyses become available.

 

If it is true that *one* woman died d/t IV use of domperidone, how do we
justify the 50 women with ruptured uterus and the death of at least 10
infants in the 12 year period between 1988 and 2000? Increased side effects
of misoprostol are more likely for women who have had previous uterine
surgery/previous cesarean delivery (around 1 of 3 women) and several
previous births (so this discounts everyone except a primip). 

 

I suspect the real difference between the 2 drugs is 1: cost of misoprostol
is almost nothing. A misoprostol induction or abortion costs less than a
dollar. A domperidone breastmilk induction could be equally low cost, but
the time of management would be measured in big dollars. Not all women are
willing to do their own legwork, find out what they need, how much they
need, how long to take. The moms I know who are inducing lactation are very
much in control of their bodies. And, 2: convenience. A misoprostol
induction or abortion is quick and "easy," unless you are one of the many
who suffer uterine "damage." A domperidone lactation induction is time
consuming, and many think, "You could just give a bottle. Who cares?"

 

Interesting thinking. And we know with what they're thinking. I also suspect
a "new and improved" very expensive drug is coming down the line, to replace
domperidone. But, it still won't be allowed for lactation induction, unless
there can be a clear monetary advantage for someone.

 

Best cynical wishes,

Sam

 


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