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A Health Canada review has found there is a risk of psychiatric withdrawal effects when women using the drug domperidone to stimulate breast milk production suddenly stop taking it.
Health Canada will update the product monograph, or scientific description of a drug’s properties “to note that cases of psychiatric withdrawal events have been reported,” the regulator said in a statement posted on its Drug and Health Product Portal. It has also issued updated guidance to doctors and other health care providers informing them of the risk.
Domperidone is a gastrointestinal medication approved in Canada to speed up digestion at a recommended maximum dose of 30 mg per day. A CBC investigation in December 2022 found it is regularly prescribed at doses several times higher than that to help women produce breast milk, a purpose for which it has never been authorized in Canada.
Domperidone is also prescribed off-label for other reasons, including to stimulate lactation using doses typically three- to five-times higher than the approved gastrointestinal use. Of the nine cases reviewed by Health Canada, eight involved doses higher than 30 mg/day to stimulate lactation.
Women told CBC that when they stopped taking the drug, they experienced extreme anxiety, panic attacks, insomnia and intrusive thoughts so severe they were left unable to function or care for their children, often for months.
Some women were forced to stop working or move in with their parents. At least one attempted to take her own life.
Montreal mom’s blog chronicled experience
Montreal resident Jamie Robinson experienced debilitating panic attacks and extreme anxiety when she stopped taking domperidone, eight months after the birth of her daughter. She recalls struggling to explain it to doctors, some of whom told her she had postpartum depression.
“I felt like there was so much difficulty in conveying the level of crisis that domperidone brought into my life that words like anxiety or depression … can’t even begin to broach the intensity of the experience,” she said.
WARNING: This story contains distressing details about suicidal thoughts and attempts. Correction: A previous version of this video included inaccurate Health Canada data about the number of domperidone prescriptions that were filled in 2020. That publicly available data has since been updated to show that 1.7 million prescriptions were filled that year.
Robinson’s psychologist, Karen White, connected her sudden and severe reactions to stopping domperidone, which blocks dopamine in the brain and can act as an antipsychotic.
At home and mentally unable to work or care for her child, Robinson went looking for reports of similar reactions and found little in the way of medical guidance. But on social media, she found dozens of other mothers who had experienced similar symptoms when they stopped taking domperidone.
She compiled their experiences into a blog in the hope, she said, that other women would have the information about stopping the medication that she didn’t.
Robinson also encouraged the women to report their symptoms to Health Canada’s Adverse Reaction Online Database.
Health Canada review confirms link
Two years later, a Health Canada review of the reports in that database and published case studies in other countries confirmed the link.
“Health Canada’s review of available information found an association between abruptly discontinuing or tapering domperidone, used off-label for lactation stimulation, and psychiatric withdrawal events including, but not limited to, depression, anxiety and insomnia,” the agency said in a statement to CBC. The review started in December 2022.
In eight of the nine cases reviewed by Health Canada, the total daily dose of domperidone was higher than the recommended maximum of 30 mg per day, the statement said.
“Domperidone should be used at the lowest possible dose for the shortest duration necessary,” the agency said.
Health Canada has issued previous warnings about the drug’s potentially dangerous cardiac side effects, and domperidone is banned in the United States for this reason.
Approximately 1.7 million prescriptions for domperidone were filled in 2021, according to Health Canada. It is not known how many were for lactation. It is also not known how often psychological withdrawal effects occur, because the only data that exists in Canada is self-reported through the adverse reaction database.
This is generally considered an undercount because people may not realize reactions could be a response to the medication or may not know of the database’s existence.
But experts interviewed by CBC generally believe such reactions to be rare.
Both the International Breastfeeding Centre in Toronto and the Herzl-Goldfarb Breastfeeding Clinic in Montreal describe domperidone as a safe medication to help stimulate lactation in women struggling to breastfeed.
Social media groups are filled with the accounts of women who have successfully breastfed their babies after taking the medication.
Tapering off medication
Dr. Bev Young is a perinatal psychiatrist in Toronto and co-founder of Bria, a virtual mental health clinic for women. Over more than two decades in the field, she says she’s seen certain reactions to domperidone many times.
“One of the questions I’ve learned to ask, especially when I see women who come in with acute anxiety, that very severe anxiety that … comes on pretty suddenly is, ‘Have you recently been on domperidone, and have you discontinued it?’ “
Tapering off the medication slowly rather than stopping cold turkey can lower the risk of such withdrawal symptoms, Young says. For women prescribed high doses, this can mean taking as long as 16 weeks to taper off.
While some women do receive such instructions from providers, Young says others do not.
And others, like Robinson, are told to taper off the drug — but only so their breast milk supply is not suddenly disrupted. Robinson wasn’t concerned about that because she had decided to stop breastfeeding, so she stopped cold turkey.
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Both Young and Robinson say having publicly available guidance from Health Canada will help women make an informed decision about whether to take the drug for this purpose.
“I think it’s a huge win,” Robinson said.
“I mean, this is really, when I started doing activism about this, this is what I was hoping for, is just that there would be more information … kind of a causal link at least established in a place that people could find it.”
If you or someone you know is struggling, here’s where to get help:
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