Health Canada has launched a safety review of the psychological withdrawal symptoms associated with stopping or reducing use of a drug commonly prescribed to help women breastfeed.

The agency confirmed the review in an email to CBC News.

“A safety review is currently under way for domperidone and drug withdrawal symptoms after stopping or reducing the dose of domperidone used to stimulate lactation,” the statement said. 

Domperidone is approved in Canada to treat gastrointestinal disorders. Health Canada has never authorized its use as a lactation aid, but it is widely prescribed off-label for this purpose. 

The Health Canada review follows a CBC News investigation into severe psychological effects that can occur when some women stop taking the drug. Women who spoke to CBC described anxiety, lack of sleep and thoughts of self-harm severe enough that in some cases they became incapable of caring for their children or returning to work. One woman described multiple attempts to take her own life. 

CBC’s investigation also found domperidone is prescribed by some doctors to stimulate lactation at doses three to five times higher than what is recommended by both Health Canada and the drug manufacturer. Because this is not an approved use or dosage anywhere in the world, there are no large-scale clinical trials that shed any light on how often these side effects occur. 

This makes it challenging for regulators like Health Canada to evaluate the safety of a drug for an off-label purpose, said Mina Tadrous, an assistant professor at the Leslie Dan Faculty of Pharmacy at the University of Toronto who specializes in drug safety.

“The company may not have intended it for that, so the original clinical trials were not designed for that. And so it means that they have to look at different mechanisms to be able to evaluate the safety of these drugs,” he said.

That can include looking at data from other countries with larger populations, according to Tadrous.

Case studies document concerns

There are, however, case studies documenting the withdrawal effects, including three published in November 2022 in the peer-reviewed journal Breastfeeding Medicine. Domperidone blocks dopamine receptors in the brain, which stimulates the release of prolactin. This causes lactation, the authors note, but can also cause domperidone to act as an antipsychotic. The authors also noted withdrawal symptoms are typically less severe when women taper off the drug slowly.

The most recent case studies are from the United States, where domperidone is not approved by the Food and Drug Administration for any purpose. CBC’s investigation found some American women get the drug from doctors in Canada.

Health Canada will review “all relevant domestic and foreign case reports,” the statement said.

Reviews can result in Health Canada requesting more information, studies or monitoring by the manufacturer. They can also result in warnings to patients and health care providers, changes to how a drug is labelled or, if necessary, the withdrawal of a drug from the market “if the benefits no longer outweigh the risks of the product,” according to the statement released by the department.

“The decision to take action, including issuing a warning, is not based solely on the number of case reports, but on a comprehensive assessment of the information contained in these case reports,” Health Canada’s statement said. 

“Should new safety risks be confirmed, Health Canada will take appropriate action and continue to keep Canadians informed.”

WATCH | Women report alarming withrawal effects after taking domperidone as a lactation aid:

Women report alarming withdrawal effects from drug prescribed for breastfeeding

2 months ago

Duration 7:08

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.

The distinction between quantity and quality of reports is important, Tadrous said, because large numbers of reports, especially from non-clinicians, may only indicate people believe there’s a connection between a drug and a reaction. 

“That’s the lesson we’ve learned with vaccines, for example, where these adverse event systems are flooded,” he said.

“And so if you base something just on the number of reports without doing a thorough investigation and a different type of study design that reduces bias … you might reach a false conclusion.”

Health Canada has conducted multiple safety reviews of domperidone, most recently in 2021. Previous reviews confirmed the risk of serious abnormal heart rhythms and sudden cardiac death related to domperidone use. These reviews resulted in Health Canada introducing a maximum daily dose recommendation of 30 mg and restricting its use in patients with certain cardiac conditions or taking other drugs.

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To be a Jew is not something special,
being a human being is normal.
Dealing with prejudice, hatred, and oppressive action,
now that’s something special for the Jewish Nation.

Oppression, hatred, and genocide besides,
is not just a Jewish person’s situation.
Armenian, Cambodian and Jewish Peoples deal,
with a national eradication event.

People of the world unit,
genocide is an international delight.
Oppress your people, crush opposition too.
The elites of the world are making exceptions for you.

Don’t be weak, allowing excuses to be made,
but lift your hands in justice’s cruel wave.
Hatred knows no reasonability, it knows no mercy.
Hatred, oppression, and prejudice need no exception.

Long ago Jews were murdered by the millions,
Cambodians died at the hands of their neighbors.
Palestine still walks within the borders of other nations,
and peace is nowhere to be found, my friend.

If your arms are in righteous ways demand justice for all,
for the people who hate will not see our peaceful ways.
A gun, a bayonet, and a saber be brought,
for the right to justice begins today,
and ends with blood if the opposition has any say.

Gandhi spoke of peaceful ways,
while Martin Luther Jr surrendered his life. to the cause.
Young blacks die each and every day,
while the power of prejudice wins the day.

My first lifts in anger that is for sure,
while the average person just shrugs this day.
But the goose-stepping troops may one day march on,
and the ignorance that prevails will let them carry on.

Open our eyes to the wrongs before us,
clear our minds and accept what bothers us.
Injustice is a prevailing horrid thing,
and ONLY YOU CAN BRING IT TO AN END.

Steven Kaszab
Bradford, Ontario
skaszab@yahoo.ca

The economy was top of mind for members of Parliament as they returned to the House of Commons Monday, with the Liberal government kicking off the new sitting with a debate on child care.

Families Minister Karina Gould tabled Bill C-35 last December, which seeks to enshrine the Liberals’ national daycare plan into law — and commit Ottawa to maintaining long-term funding.

The federal government has inked deals with provinces and territories in an effort to cut fees down to an average of $10 per day by 2026.

During a debate today, Gould said all parties should support the bill, and the national plan has begun saving families money.

But Conservative MP Michelle Ferreri said the plan is “subsidizing the wealthy” while failing to reduce wait times for child-care spaces and address labour shortages in the sector.

Ferreri told MPs that the Conservatives would be presenting “strong amendments” to the legislation.

The debate comes amid concerns about a possible recession this year, with both Prime Minister Justin Trudeau and Conservative Leader Pierre Poilievre saying their focus will be on the cost of living.

But Poilievre’s Tories may have little room to manoeuvre in the legislature.

NDP Leader Jagmeet Singh told reporters upon his return to the House of Commons that he does not believe there is any room to work with the Conservatives during the upcoming sitting.

Instead, the NDP says it plans to push the Liberals to fulfil the terms of the parties’ confidence-and-supply agreement, such as the planned expansion of federal dental care.

Under the deal signed last March, the NDP agreed to support the minority government on key House of Commons votes in exchange for the Liberals moving ahead on New Democrat policy priorities.

This report by The Canadian Press was first published Jan. 30, 2023.