Health Canada is conducting a safety review of domperidone, a drug often prescribed off-label to breastfeeding mothers as a way to boost milk supply, after reports have alleged withdrawal symptoms and psychiatric concerns after stopping the medication.
A spokesperson for Health Canada told the Epoch Times in an emailed statement that it is “proactively” monitoring the safety of domperidone maleate.
The safety review of the drug began in December 2022 and is not expected to be completed until the summer of 2023, which Health Canada says was “prompted by domestic and foreign case reports of withdrawal symptoms after stopping or reducing the dose,” in cases where it was used to stimulate lactation, said the spokesperson.
The drug has been approved for use in Canada since 1985. It is typically prescribed for the management of gastrointestinal disorders like gastritis and diabetic conditions. It is also used to prevent nausea and vomiting from other medications.
The paper cited three U.S. patients who used domperidone to help lactation and experienced “varying degrees of psychiatric withdrawal symptoms lasting months,” when they reduced their dosage and eventually stopped taking the drug.
The authors noted that this occurred in the same time frame when women could experience symptoms of postpartum depression. The authors suggested a slow tapering off of the dosage “may minimize withdrawal symptoms in these patients.”
Health Canada said the safety review will study manufacturer reports, adverse reaction reports from health professionals and consumers, academic research, surveillance, and other available data from Canada and abroad, to evaluate the medication’s safety risk.
The regulator will also consider the severity and frequency of adverse events, what other products are available that can treat the same condition, and the patient population typically prescribed the medication.
U.S. Ban
Domperidone was banned in the United States after it was linked with fatal cardiac arrhythmias in cancer patients who were taking the drug to combat nausea and vomiting.Health Canada said domperidone has never been licensed in Canada for breastfeeding women, but is prescribed off-label because it is known as a galactagogue, meaning it improves lactation and boosts milk supply in new mothers, mainly by stimulating the production of prolactin.
Health Canada previously warned that domperidone has a risk of adverse reactions, heart arrhythmia, and potential cardiac events including death, and warned doctors not to exceed a recommended daily dose of 30mg.
