Limited evidence for effectiveness, but considerable information on cardiac risks of domperidone
MONDAY, May 15, 2017 (HealthDay News) — 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, M.D., M.P.H., from the U.S. Food and Drug Administration in Silver Spring, Md., and colleagues discuss the safety issues associated with use of domperidone. The authors note that although domperidone is approved for certain gastrointestinal disorders in some countries, it is not approved for any human use in the United States, and is associated with serious cardiac arrhythmias. An FDA import alert was issued in 2004 and updated in 2012, explaining that domperidone import is illegal, with limited exceptions.
A public safety warning has been issued regarding use of domperidone for lactation; however, domperidone is sometimes obtained illegally and used by lactating mothers to increase milk production. Limited quality evidence is available for the effectiveness of domperidone in enhancement of lactation, while considerable evidence is available on the cardiac risks associated with domperidone, which include 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 authors write.
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