Okay guys, this is unacceptable and needs to be addressed. Some other breastfeeding professionals are going to be getting behind challenging this, so I'll let you know where to send your letters!

I do not accept this information and want to get the message back to them. In Canada, this is a commonly-used medication for milk production, and anything the US does is often followed by the rest of the world, unfortunately!

The "risks" they mention are standard with many many drugs that the medical world accepts as worth those potential drawbacks. Isolating a drug used for breastfeeding is no coincidence, as far as I'm concerned. Look at all the other drugs being used for off-label purposes (cytotec comes to mind) without a care for potential risks. Again, the money speaks, in my opinion. The establishment is not supportive of breastfeeding. If there is no research or support behind this drug, why doesn't someone do some scientific studies? I'm sure there are enough of us adoptive Mamas who could vouch for its effectiveness and safety!
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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.