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.
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“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.
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.
Marie Tarrant, a professor in the School of Nursing at the University of British Columbia, said the off-label use of domperidone is “one of the most controversial topics in breastfeeding.”
“A lot of people argue that this is a completely safe drug, it’s very effective and that people are overstating all of the potential side effects which are very, very rare,” said Tarrant. “People on the opposite side think that this should not be used at all as off-label for increasing breast milk production.”
Tarrant said while off-label drug use— where a drug is prescribed for something that it wasn’t intended for or approved for— is a very common practice, she hopes Health Canada’s safety review could provide clearer recommendations on using domperidone to increase breast milk supply.
In early December, CBC News reported cases of women who took domperidone experiencing serious symptoms including severe anxiety, depression, intrusive disturbing thoughts and insomnia while trying to stop taking the drug.
Case studies have also documented those effects, including a research paper published in December by the InfantRisk Center at Texas Tech University Health Sciences Center.
Tarrant said since postpartum women do get postnatal depression, it is unclear whether the stopping of domperidone is actually increasing the risk of that or is coinciding with some of these postpartum issues.
“That’s why I think they need to do the safety review,” said Tarrant.
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People who breastfeed should only take domperidone when they have “exhausted all of the first line ways of increasing milk supply” that are known, said Jessica Bawden, a nurse practitioner in family practice at the Women’s College Hospital and an international board certified lactation consultant.
“The best way to increase milk supply is to challenge the body over a period of many weeks, to make more milk by mechanical removal, by the baby, or by a pump,” Bawden said. “So at least eight times in 24 hours, we’re thoroughly draining the breast.”
Bawden said domperidone could be “a reasonable and safe option” for young people who breastfeed as long as the individual doesn’t have any cardiac conditions and taking any other drugs that can also affect their heart rhythm.
Domperidone antagonizes dopamine, which allows prolactin— the milk-making hormone — to rise, Bawden said.
“If you’ve tried all of this, you’ve gotten support, you feel like you really want to just throw everything at it, domperidone a really reasonable thing to try,” Bawden said.
Bawden added that when using domperidone, individuals should be monitored closely.
Individuals who decided to stop using domperidone should talk to their health-care providers about reducing the dosage slowly rather than stop taking the drug all of the sudden, Bawden said.
“Further evidence around weaning (off the drug) and suggestions hopefully will come from Health Canada after their review,” Bawden said. “I’m looking forward to that guidance for my clinical practice and for my patients as well.”
— with files from Motorcycle accident toronto today’ Amanda Connolly and The Canadian Press
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