FDA warning against domperidone use by lactating mothers to increase milk production.

The dopamine receptor antagonist domperidone, which may increase milk production in lactating women, is associated with serious cardiac risks, and should not be used for lactation enhancement, according to a commentary published in the June issue of Obstetrics and Gynecology.

Catherine A. Sewell, MD, MPH, from the U.S. Food and Drug Administration in Silver Spring, Maryland, and colleagues published this commentary to discuss the safety issues associated with use of domperidone and to raise the awareness among healthcare providers in US against the use of domperidone as galactagogue.

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.

According to a release by FDA “The serious risks associated with domperidone include cardiac arrhythmias, cardiac arrest, and sudden death. These risks are related to the blood level of domperidone, and higher levels in the blood are associated with higher risks of these events.”

The U.S. Food and Drug Administration (FDA) issued an import alert in 2004, updated in 2016, explaining that the importation of domperidone is illegal with limited exceptions, including when imported pursuant to an investigational new drug application.

A public safety warning has already been issued for domperidone, as the drug is sometimes illegally obtained from other countries and used to enhance milk production.

Only scant evidence exists to support its use as lactation enhancer but considerable information exists on domperidone's cardiac risks including QT prolongation, torsades de pointes, and sudden cardiac death, including among lactating women.

“In light of limited efficacy data that do not offset safety concerns from a public health perspective, we continue to caution against using domperidone for lactation enhancement,” the commentary states.

The FDA warning release can be accessed here.