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Health Canada reviewing safety of controversial breastfeeding drug

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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.

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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.

Toronto pharmacist Mina Tadrous says it is challenging for regulators to evaluate the safety of a drug used for off-label purpose. (CBC)

“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.”

 

Women report alarming withdrawal effects from drug prescribed for breastfeeding

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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Pakistan airline crew sought asylum in Canada: spokesperson – CTV News

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Typically, Pakistan International Airlines (PIA) flight attendants who arrive in Toronto stay at a hotel overnight, meet back up with their crew the next day and then fly to their next destination.

But increasingly often, PIA attendants aren’t showing up, the airline says. According to PIA, at least eight flight attendants disappeared over the last year and a half.

They have abandoned their jobs and are believed to have sought asylum in Canada, a spokesperson for the government-owned airline says.

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Increased occurrences

Abdullah Hafeez Khan said at least eight flight attendants “have gone missing” after flying to Pearson International Airport in Toronto. He said these incidents have been happening over the last 10 years, but are now occurring more frequently.

“Since probably October of 2022, the number of the people that have opted asylum has increased tremendously,” Khan said in a video interview with CTVNews.ca from Karachi, Pakistan, where the airline is based.

“None of those crew members that disappeared in the last one-and-a-half years have come back. So they were granted asylum for one way or the other, and that probably has encouraged others to do so.”

The missing employees were fired immediately and lost their company benefits, Khan said.

Why did they flee?

Khan said he could only speculate as to why the flight attendants would flee.

The Canadian government underscored the volatile situation in Pakistan, warning in a travel advisory of a “high threat of terrorism,” along with threats of civil unrest, sectarian violence and kidnapping.

“The security situation is fragile and unpredictable,” the Canadian travel advisory reads. “Incidents are typically attributed to extremism, ethnic divisions, sectarian strife, regional political disputes and the situation in neighbouring Afghanistan.”

It added that many deaths and injuries have occurred from bombings, shootings and other terrorist attacks at a wide range of targets.

Since Khan isn’t in contact with any of the missing employees, he says, he assumes they decided to seek asylum in Canada for economic and social reasons.

“So I naturally assumed that all of them have been given asylum because I don’t think they would be living there illegally,” he said, adding they may already have family connections in Canada who can support them.

In this June 8, 2013, photo, a Pakistan International Airlines plane moments before take off from the Benazir Bhutto airport in Islamabad, Pakistan. (AP Photo/Anjum Naveed)

‘PR crisis’

Khan called the flight attendants’ disappearances a “PR crisis” for PIA that is “bad” for business amid a crew shortage.

The airline is in talks with the Canada Border Services Agency (CBSA) and Pakistani law enforcement agencies to potentially create a “legal safeguard” to curtail flight crew from seeking asylum, he said.

When asked about the PIA flight attendants’ disappearances, Erin Kerbel, spokesperson for Immigration, Refugees and Citizenship Canada, said the department couldn’t comment on specific cases due to privacy legislation.

In response to questions about PIA’s claim that discussions are underway about the issue, a spokesperson for the CBSA said it could not confirm any information.

“The Canada Border Services Agency does not provide comment or details on specific individuals, including any discussions that would take place with airline companies, as an individual’s border and immigration information is considered private and protected by the Privacy Act,” Maria Ladouceur said in an email to CTVNews.ca.

Since the crew members’ disappearances, Khan said, the airline has “done numerous things to curtail that.”

For instance, the airline is only staffing Toronto-bound flights with crew members who have “established linkages” in Pakistan, such as children, spouses or parents, as well as those who have worked in the organization for more than 15 years.

The airline avoids sending to Toronto those who are single or don’t have established family ties in Pakistan, he said.

Khan said he and the airline are no longer in contact with the flight attendants because, they discovered, they usually change their phone numbers soon after disappearing in Toronto.

Who disappeared?

The PIA flight attendants who vanished in Canada are seasoned pros in their late 30s or 40s, some of whom have worked for the airline for as long as two decades, Khan said.

“There was never any sign from them that they would seek something like that,” he said. “So that is something that is bothering us in the matter because working with people who have been working with you for a long time and then something happens like this is pretty unexpected.”

In one of the latest cases in February, the crew members were waiting to take the bus back to the airport from the hotel in Toronto and one of the flight attendants didn’t show up, Khan said.

The airline was unable to reach the flight attendant on her cellphone or hotel landline so, Khan says, they asked hotel management to check if she was OK.

“When the crew went there, she left her uniform there with a note saying, ‘Thank you PIA,'” Khan said, which he interpreted as a genuine sentiment of gratitude for her more than 15 years of service with PIA rather than a taunt.

Khan said the crew members who disappeared were “family values people” who had good careers in Pakistan.

Asylum policies

Individuals can make a refugee claim in Canada at a port of entry upon arrival or online if they are already in Canada, according to the Canadian government’s website.

Canadian immigration or border officials will determine if the person is eligible for a hearing before the Immigration and Refugee Board. All claimants must undergo health and security screenings, the government says.

If eligible to make a claim in Canada, refugee claimants can access social assistance, education, health services, emergency housing and legal aid pending a decision on their claim. Most can apply for a work permit after a medical examination.

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Alberta's population surges by record-setting 202,000 people: Here's where they all came from – CBC.ca

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Alberta smashed population-growth records in the past year, mainly due to people moving to the province from across Canada and around the world.

The province’s population surged to just over 4.8 million as of Jan. 1, according to new estimates released Wednesday by Statistics Canada.

That’s an increase of 202,324 residents compared with a year earlier, which marks — by far — the largest annual increase on record.

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Alberta also broke a national record in 2023 for interprovincial migration, with a net gain of 55,107 people.

“This was the largest gain in interprovincial migration nationally since comparable data became available in 1972,” Statistics Canada said in a release.


Most of the interprovincial migrants came from Ontario and British Columbia.

Statistics Canada estimates that 38,236 Ontarians moved to Alberta last year, versus 14,860 Albertans who moved to Ontario, for a net gain of 23,376 people.

Similarly, an estimated 37,650 British Columbians moved to Alberta, compared to 22,400 Albertans who moved to B.C., for a net gain of 15,250.


All told, interprovincial migration accounted for 27 per cent of Alberta’s population growth over the past year.

That put it just ahead of permanent immigration, which accounted for 26 per cent, and well ahead of natural population increase (more births than deaths), which accounted for eight per cent.

The largest component, however, was temporary international migration.

Non-permanent residents from other countries accounted for 39 per cent of the province’s population growth in the past year, reflecting a national trend.


Canada’s population reached 40,769,890 on Jan. 1, according to Statistics Canada estimates, which is up 3.2 per cent from a year ago.

“Most of Canada’s 3.2-per-cent population growth rate stemmed from temporary immigration in 2023,” Statistics Canada noted.

“Without temporary immigration, that is, relying solely on permanent immigration and natural increase (births minus deaths), Canada’s population growth would have been almost three times less (1.2 per cent).”

Alberta’s population, meanwhile, grew by 4.4 per cent year-over-year.

Alberta now represents 11.8 per cent of the country’s population, its largest proportion on record. 

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Why Canada's record population growth is helping – and hurting – the economy – CTV News

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Canada has recorded the fastest population growth in 66 years, increasing by 1.3 million people, or 3.2 per cent, in 2023, according to a new report from Statistics Canada.

The country has not seen such growth since 1957, when the spike was attributed to the baby boom and an influx of immigrants fleeing Hungary.

The vast majority of Canada’s growth last year was due to immigration, with temporary residents — which includes foreign workers and international students — making up the largest proportion of newcomers.

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“We need people coming to Canada to help with our economy,” says Matti Siemiatycki, a professor of planning at the University of Toronto. “There are many jobs and professions where there are vacancies, and that is having an impact, whether in the healthcare sector or trades and construction sector.”

Siemiatycki adds immigrants also bring “ingenuity… resources… and culture” to Canada.

Newcomers are relied on to help keep pace with Canada’s aging population and declining fertility rates, but the influx also presents a challenge for a country struggling to build the homes and infrastructure needed for immigrants.

“It’s an incredibly large shock for the economic system to absorb because of just the sheer number of people coming into the country in a short period of time,” says Robert Kavcic. a senior economist and director with BMO Capital Markets.

“The reality is population can grow extremely fast, but the supply side of the economy like housing and service infrastructure, think health care and schools, can only catch up at a really gradual pace,” Kavcic says. “So there is a mismatch right now.”

The impact of that mismatch can most acutely be seen in the cost of rent, services and housing.

In December, Kavcic wrote in a note that Canada needs to build 170,000 new housing units every three months to keep up with population growth, noting the industry is struggling to complete 220,000 units in a full year.

To address this, Ottawa has announced plans to cap the number of new temporary residents while also reducing the number of international student visas, a move economists say could offer some relief when it comes to housing and the cost of living.

“The arithmetic on the caps actual works relatively well because it would take us back down to 1 per cent population growth which we have been used to over the last decade and which is more or less absorbable by the economy,” Kavcic says. “The question is whether or not we see policy makers follow through and hit those numbers.”

Economists believe these changes could help ease inflationary pressures and may make a Bank of Canada rate cut more likely, but could also lead to slower GDP growth.

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