On May 4, the Ministry of Food and Drug Safety cautioned mothers taking “domperidone,” an emetic, against breastfeeding their babies.
Domperidone, also known as Motilium, is used to relieve nausea, vomiting, indigestion, and to promote lactation. The U.S. Food and Drug Administration illegalized the drug developed by Janssen Pharmaceutica in 2004 because of “potential health risks associated with the use of domperidone by lactating women to enhance breast milk production.” The risks include cardiac arrhythmias, cardiac arrest, and sudden death.
|A government guideline on the use of domperidone, an emetic, by breastfeeding women has caused criticism from domestic pediatricians for blindly following the U.S. and European standards.|
It has sparked a controversy among related groups in Korea. Doctors had prescribed domperidone with little problems until October 2016 when Rep. Jeon Hye-sook전혜숙 of the Democratic Party criticized the standard prescription of domperidone for breastfeeding and pregnant women, citing the U.S. FDA had banned the drug 10 years ago.
She pointed out how freely doctors had prescribed the drug, which could have potentially fatal consequences.
The Korean ministry held a meeting in November to evaluate the regulations of the drug. They reached two conclusions: first, stop giving domperidone to pregnant or potentially pregnant women. Second, if lactating women want to take this medication, they should suspend breastfeeding while taking it.
The FDA’s decision created strong opposition from the Korean Pediatrics Association (KPA) and the Korean Association of Obstetricians and Gynecologists. The KPA filed a suit against the assemblywoman for slandering doctors, by saying they had prescribed domperidone with little caution.
"Newborns consume less than 0.1 percent of the dose adjusted for the mother's weight,” KPA said in a statement. “Breastfeeding is not a matter of choosing rice or bread. The ministry is overlooking the significance of breastfeeding and the health of the mother."
Noting that the European Medicines Agency (EMA)’s regulations have served as the basis for the ministry’s changing its contents of approval, a KPA official quoted the EMA regulations as stipulating that “A decision should be made whether to discontinue breastfeeding or to discontinue/abstain from domperidone therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.”
The official said the EMA has provided leeway for doctors to prescribe domperidone to breastfeeding women according to their discretion.
In comparison, the Korean approval states that “one must stop either breastfeeding or stop taking domperidone after considering the benefit of breastfeeding for the child versus the treatment for the mother.”
The KPA criticized these changes, saying that “the ministry’s approval, based on the EMA’s approval, has copied the latter word by word except for the conclusion about breastfeeding women. We requested changing it last December, but has yet to see any improvement.”
The association emphasized that the ministry is creating unnecessary anxiety for both pediatricians and mothers, and therefore should take responsibility."
<© Korea Biomedical Review, All rights reserved.>