Health Canada reviewing safety of breastfeeding drug domperidone

Health Canada is conducting a safety review of domperidone given its off-label use for increasing breast milk supply in postpartum women, the agency said in a statement on Tuesday.

The safety review, which started last month, is looking at drug withdrawal symptoms after stopping or reducing the dose of domperidone used to stimulate lactation, Health Canada said.

“Health Canada is aware that domperidone has been prescribed off-label to promote lactation in postpartum women. A safety review is currently underway,” the agency said.

“This safety review includes critical evaluation of information from both domestic and global post-marketing surveillance and epidemiological research to further characterize this potential safety risk. All relevant domestic and foreign case reports are being thoroughly evaluated.”

The agency noted that domperidone is not been authorized for use in increasing lactation in Canada.

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Officially, domperidone has been approved by Health Canada for treating gastrointestinal disorders since 1985.

Health Canada said they will inform Canadians and “take appropriate action” if there are any new safety risks confirmed, adding that the safety review was “prompted by domestic and foreign case reports of withdrawal symptoms after stopping or reducing the dose of domperidone used to stimulate lactation.”

Domperidone is associated with potential cardiac risks, including sudden cardiac death, Health Canada warned on its website. The agency issued two separate safety alerts about domperidone and the risk of “serious abnormal heart rhythms and sudden death (cardiac arrest) in 2012 and 2015.

— with files from Global News’ Amanda Connolly

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