Health Canada conducts safety review on breastfeeding drug amid psychiatric concerns

A mother is seen breastfeeding her child in this file photo. (Juan García Aunión / Istock.com)

Health Canada is reviewing the safety of domperidone amid reports that some breastfeeding mothers in Canada and the U.S. have had serious psychiatric symptoms when they tried to stop taking the drug.

Domperidone is approved in Canada for gastrointestinal symptoms but is frequently prescribed off-label to increase breastmilk supply.

Health Canada confirmed to The Canadian Press on Tuesday that it started the safety review in December.

Early that month, CBC News reported cases of women experiencing symptoms including severe anxiety, depression, intrusive disturbing thoughts and insomnia while trying to stop taking the drug.

When used to promote lactation, domperidone is routinely prescribed in higher amounts than approved by Health Canada.

The FDA has banned the drug in the U.S. because of concerns about potential cardiac side effects.

Breastfeeding consultants say they advise women who want to stop taking domperidone to wean off it gradually.

This report by The Canadian Press was first published Jan. 31, 2023.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

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