Banned in the U.S., not approved for breastfeeding — why are so many moms taking this drug?

WARNING: The story contains details about suicidal thoughts and attempts.

For Jamie Robinson, the changes were subtle at first.

She found herself playing with her hair and bumping into things. But soon, she was having six or seven panic attacks a day. Things then escalated to intrusive thoughts to take her own life and punch herself in the face. Robinson, 39, knew at that point something was terribly wrong.

“I’m looking at my own baby,” the Montreal woman recalled, “this warmth that floods me had just died completely.”

“This reoccurring thought that she had been replaced, that this was not my baby, that this was maybe even a robot baby because there was no emotional engagement from my side… And the emotions are rushing to that space. The guilt, the feeling of panic. Like, am I a bad mom? Am I losing my mind?”

When her psychologist saw the distress she was in, she zeroed in on a breastfeeding medication Robinson had recently stopped taking. The medication was domperidone, a gastrointestinal drug that can also induce lactation.

But domperidone also acts as an antipsychotic, and psychologist Karen White believes Robinson was suffering withdrawal symptoms.

“[It] kind of clicked because I’ve seen people have very extreme reactions to stopping different medications,” White recalled. “And we kind of went, ‘oh, that could be it.'”

Drug prescribed off-label

Domperidone, which blocks dopamine in the brain, is approved in Canada as an aid to speed up digestion, but it also has a side effect: lactation. Doctors and midwives routinely prescribe it off-label for this purpose. More than 120 million prescriptions for domperidone were filled in 2020, according to Health Canada.

Thousands of mothers describe it in online forums as a wonder drug that helped them produce enough milk to breastfeed their babies.

“It kind of sounded like a miracle drug,” said Emily Matreal, 29, who lives just outside Detroit and took domperidone in 2021 to help her breastfeed her son, Conner.

Health Canada told CBC that although the agency is aware the drug is routinely prescribed to stimulate lactation, it is not approved for that purpose.

CBC spoke with nine women in Canada, the U.S. and Australia who say they had debilitating psychological side effects when they tried to come off the drug. They described 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 were forced to stop working or move in with family. At least one attempted to take her own life. They all say no one warned them these things could happen.

Multiple experts interviewed by CBC said they believe such side-effects are rare.

“It’s very unpredictable,” said researcher Janet Currie, who wrote her doctoral thesis on postpartum domperidone prescriptions in British Columbia. She says she’s helped between 15 and 20 postpartum women with severe psychological side effects slowly taper off the drug in the last year.

“No one can tell you exactly in advance whether you’ll have these symptoms and how intense they will be.”

Domperidone is not approved as a lactation aid anywhere in the world and there are no large-scale clinical trials that shed any light on how often these side effects occur.

 

Canadian data does not give the reason a person was prescribed a drug. But a CBC analysis of partial data from B.C., Saskatchewan, Manitoba and publicly-insured residents of Quebec found that of the nearly two million people prescribed domperidone between 2000 and 2021, more than three-quarters were women in their childbearing years.

The only published accounts of severe psychological withdrawal symptoms are case studies, including three published last month in the Journal of Breastfeeding Medicine.

Health Canada has issued several warnings about domperidone, but for cardiac side effects, not withdrawal symptoms. In 2012, 2015, and 2022,  the agency noted it can cause irregular heart rates and sudden cardiac death.

Health Canada’s warnings about domperidone, which echo those from the manufacturer in the product monograph, say it should be prescribed at doses no higher than 30 milligrams per day for the shortest possible period. The European Medicines Agency has similar guidelines.

Banned in the U.S.

In the United States, domperidone is banned, for any purpose, by the Food and Drug Administration (FDA) due to cardiac risks. But the FDA ban hasn’t stopped Americans desperate to breastfeed, like Matreal outside Detroit, from seeking it out.

When Matreal’s breast milk supply dropped off at three months postpartum, she posted in a Facebook mom’s group asking for advice. That was where she learned about domperidone — and how to get it in the U.S., through a well-known Canadian doctor.

“I thought, ‘well, that sounds safe. I will reach out to the doctor and kind of see how this goes’,” Matreal said.

That doctor is Jack Newman, a pediatrician who runs the International Breastfeeding Centre in Toronto and is one of the best-known physicians in the field. Newman’s books and online reference materials on using domperidone to stimulate lactation are widely cited as evidence the medication is safe for this purpose in breastfeeding support groups with members around the world.

In an interview with CBC, Newman emphasized that if women were well supported by the health-care system to breastfeed from the beginning, domperidone wouldn’t be needed. Lactation consultants at his clinic watch mothers nurse and recommend other techniques, such as correcting a latch or breast compression, before turning to medication, he added.

He says the risks identified by regulators are overblown.

“We’ve never had a mother have a cardiac arrest. And I’m talking about thousands of mothers that we’ve treated over the years,” Newman said.

“The dose of domperidone that Health Canada recommends —  it’s not a ‘you must do this’ — is useless, it’s not going to work. And so we with experience know that three tablets three times a day, and sometimes we go higher than that, actually helps, and it helps in the majority of mothers.”

Newman starts patients at 90 milligrams per day — three times Health’s Canada’s maximum daily recommendation — and sometimes goes as high as 160 milligrams.

‘Our lives kind of started to unravel’

Matreal paid $100 and was able to get a virtual appointment with a lactation consultant at Newman’s International Breastfeeding Centre in Toronto the next day.

The consultant presented her case to Newman, who prescribed domperidone at 90 milligrams per day. The clinic sent the prescription to a pharmacy in Vancouver, which shipped the medication to Matreal’s doorstep.

When her breast milk supply didn’t increase, Matreal got in touch with the lactation consultant at the clinic, who recommended increasing the dose to 120 milligrams.

At this dose, Matreal said she started producing “a good amount of milk.” Three months later, she decided to stop taking the drug.

Matreal says she was warned by the Newman clinic to wean slowly so her milk supply was not disrupted, and that there could be some anxiety. She tapered slowly at first, but then, in her eagerness to be done with pumping and freezing milk, decided to stop altogether.

Two days after going off the drug, Matreal noticed changes: dry eyes, hot flashes and sweating.

“There was just a deep feeling of panic. I didn’t have an appetite, I couldn’t eat, I couldn’t unwind, I couldn’t sleep…. And then our lives kind of started to unravel from there.”

Matreal tried to get answers from the medical community, including from Newman. In an email dated Oct. 10, 2021, viewed by CBC, she wrote to Newman, saying she was “suffering horrible, horrible anxiety” trying to come off the drug.

In an email response the next day, also viewed by CBC, Newman suggested she either take an anti-anxiety medication her doctor had recommended, or go back on domperidone and wean “very slowly, over six months, say.”

“Your situation is very unusual, by the way, since I have not heard of anyone having symptoms like you describe after only three months of taking it,” he added.

Matreal tried going back on domperidone, she said, but her symptoms persisted. She said she found some comfort when she went back to the online mom’s forums and found dozens of other women who said they experienced the same symptoms when they stopped taking the drug.

‘Heartbreaking’

It’s a familiar story to Dr. Kaitlyn Krutsch, an assistant professor at the InfantRisk Center at the Texas Tech University Health Sciences Center School of Medicine, and author of three recently published case studies on domperidone withdrawal.

The Center, which studies the amounts of drugs that get into breastmilk, gets about half a dozen calls a week from American women in crisis trying to come off domperidone and unable to find answers from their doctors, Krutsch said. Women are reluctant to disclose they’ve been taking a banned drug, Krutsch explained. And even when they do, she said, American doctors don’t know what it is.

Many of the women, she added, get the drug from Canada.

“It’s heartbreaking,” she said. “A lot of times we’ll hear from the same moms over and over that they’re really struggling, that they’re having a lot of trouble with depression, that they’re having trouble functioning in their daily lives, that they don’t want to get out of bed. We even hear that they are suicidal.”

Krutsch said domperidone withdrawal can look a lot like postpartum depression, which can lead some health-care providers to assume that’s what’s wrong.

But there are important differences, Krutsch noted. In the case studies she published, women would experience symptoms within days of stopping the drug. When they went back on, symptoms would wane, she explained. In addition, one of the women in her case study was an adoptive mother who used domperidone to induce lactation. She was never pregnant.

In Montreal, Robinson’s psychologist Karen White also had her doubts that what she was seeing was postpartum depression. White, who has Robinson’s permission to discuss her case with CBC, said Robinson had what she considered to be a normal amount of anxiety for a first-time parent after the birth.

But when White saw Robinson several months later, Robinson’s level of distress alarmed her.

“I’ve seen very severe postpartum depression and anxiety, and this looks similar, but occurring so long after the birth and when she had been doing very well, didn’t make sense to me.”

Robinson says a lactation consultant at the Herzl-Goldfarb Breastfeeding Clinic in Montreal suggested she try domperidone. A doctor working at the clinic prescribed it.

The Herzl-Goldfarb clinic did not respond to a request for comment.

 

‘It would be better for everybody’

Matreal eventually stopped getting out of bed. She and her husband sold their house and moved in with Matreal’s parents so her mother could help take care of the baby. Unable to function, Matreal says she started to feel like a burden.

She tried to take her own life shortly after Conner turned one, and again around Mother’s Day.

“I 100 per cent felt like if I wasn’t here anymore, causing all of this, it would be better for everybody,” she said.

When CBC discussed Matreal’s case with Newman, he said anyone prescribed through his clinic gets comprehensive information about how to wean off domperidone slowly and is welcome to get in touch with the lactation consultants at the clinic if they run into problems.

He said such side effects are rare in his patients, and what’s more likely is the drug was masking symptoms of postpartum depression or anxiety that were already there.

“What is common in our patients, or anybody’s patients, is postpartum depression or anxiety. These mothers have been on the domperidone for several months and then small amounts of domperidone enter into the brain and act as an antidepressant. And when they go off it, especially if they go off it quickly, [they have] symptoms of maybe what is really the postpartum depression rather than the effect of the domperidone,” he said.

He said he prescribes the drug to American women about five or six times every few weeks, and that the FDA’s reasons for banning the drug are baseless.

“The FDA has said a lot of rubbish in the years …and they’re wrong about domperidone, to say it’s a particularly dangerous drug.”

Newman added that in the U.S., domperidone “isn’t actually banned because veterinarians can use it. So, you know, a million-dollar race horse is much more important than a mother.”

Asked if he’s ever advised American women to get the drug from a veterinarian, Newman replied: “Yes, but they don’t do it.”

Newman also said the clinic’s patients are warned about psychological withdrawal effects if they don’t taper off slowly, but CBC found no evidence of such warnings in reviewing the documentation Matreal received from his clinic.

The website of Newman’s International Breastfeeding Centre notes some women can experience anxiety and depression if they stop taking the drug too quickly, but says it is unlikely domperidone is responsible and that the same thing can happen to women who abruptly stop breastfeeding.

The College of Physicians and Surgeons of Ontario says doctors who provide care in other jurisdictions must do so in compliance with the college’s drug prescription guidelines  — “as well as any relevant legal or professional obligations in their patient’s jurisdiction,” the college said in a statement.

Sharing the stories

A year after she stopped taking domperidone, Matreal laughs as she lunges for a toy Conner tosses in her direction as he toddles by. The family has moved into their own apartment and life is starting to feel normal again, she said.

“When I hear music, it kind of feels good again, and I’m spending time with my son.”

Matreal said she wants to share her story because hearing from other women who had been through the same thing was what helped her when she was at her lowest.

“It was displayed as an overall pretty safe drug, but then it’s so powerful that it can flip your life upside down,” she reflected.

“I guess that’s been the biggest thing, is just wanting to get my story out there and try to help people and kind of make them more aware that it might not just be a drop in breast milk and some anxiety. It could be a lot more.”

Back in Montreal, Robinson has created a website where she posts stories of other mothers who have had traumatic withdrawals from domperidone.

She said she’s doing it so other women have the information she was never given.

“I think that if women knew what the potential risk was … I don’t think almost any mother would take this risk of not being able to care for their child. It’s a nightmare.”

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If you or someone you know is struggling, here’s where to get help:

CBC obtained data on the number of domperidone prescriptions from B.C., Saskatchewan and Manitoba, broken down by age range and gender, from the Canadian Institute for Health Information. Data from B.C. and Saskatchewan was from 2006-2021. Data from Manitoba was from 2015-2021. CBC designated “childbearing years” for these provinces as 15-54 (the 15-24 through 45-54 age buckets).

Data for Quebec came from the Régie de l’assurance maladie du Québec and included prescriptions for domperidone between 2000 and 2021 for publicly insured residents, which constitutes just under half the province. CBC designated “childbearing years” for Québec as 11-50 (the 11-20 through 41-50 age brackets). In total, the data included prescriptions for 1,974,475 unique individuals. The data did not include the reason the person was prescribed domperidone.

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