Warning Breast-Feeding Mothers about Domperidone
FDA Patient Safety News: Show #30, August 2004

Here's a warning to pass on to patients who are breastfeeding their babies. FDA has received numerous reports of pharmacies compounding the drug domperidone and of lactating women using the drug to try to increase their milk production.

Domperidone isn't approved for that indication, and in fact it's not approved for any indication in this country. It's also not approved in any country for increasing breast milk production. (It’s been approved in several foreign countries, but only to treat certain gastric disorders.)

U.S. women using domperidone have been buying it from compounding pharmacies in this country, and also online from sources outside the U.S.

FDA is concerned that women may be risking their health if they use domperidone to try to increase milk production. There are reports of cardiac arrhythmias, cardiac arrest and sudden death in patients receiving an IV form of the drug, and in fact that form is no longer marketed.

At high oral doses, seizures and other neurologic side effects have been reported, and those are the doses that have been suggested for breastfeeding women. In addition, using certain other drugs, such as erythromycin, could raise blood levels of domperidone even further and increase the possibility of serious adverse effects. In several countries where the oral form of domperidone is marketed, the drug's labeling specifically warns that nursing mothers should not use it.

Using domperidone may place the infant at risk, too. That’s reflected in the labeling in many countries where the drug is approved for other purposes. The labeling notes that the drug is excreted in breast milk, and that could expose a breastfeeding infant to unknown risks.

The bottom line is to advise patients who are breastfeeding not to use domperidone to try to increase their milk supply.

Additional Information:

FDA Talk Paper: FDA Warns Against Women Using Unapproved Drug, Domperidone, to Increase Milk Production.
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm173886.htm


FDA Patient Safety News is available at www.fda.gov/psn