Health Canada conducts safety review on breastfeeding drug amid psychiatric concerns

Health Canada is reviewing the protection of domperidone, a drug prescribed off-label to enhance breast milk supply, amid reports that some moms in Canada and the U.S. have had serious psychiatric symptoms once they tried to stop taking the drug.

Domperidone is approved in Canada for treating gastrointestinal symptoms but is continuously prescribed for fogeys facing breastfeeding challenges.

“The security review, which began in December 2022, was prompted by domestic and foreign case reports of withdrawal symptoms after stopping or reducing the dose of domperidone used to stimulate lactation,” Health Canada said in a press release on Tuesday.

“Domperidone products haven’t been authorized by Health Canada to be used in lactation promotion.”

When used to assist with breastfeeding, domperidone is routinely prescribed in higher amounts than the 30 mg a day approved by Health Canada for gastrointestinal symptoms.

For instance, the International Breastfeeding Centre, a widely known clinic based in Toronto, typically recommends breastfeeding moms start with 90 mg a day. Its founder, Dr. Jack Newman, said the medication has helped a lot of his patients.

In early December, CBC News reported cases of girls who took domperidone experiencing serious symptoms including severe anxiety, depression, intrusive disturbing thoughts and insomnia while attempting 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.

Although he’s not aware of any clinical trials examining possible psychiatric effects of domperidone amongst breastfeeding moms, it’s necessary to listen to the “signal” these case studies are sending, said Dr. Jonathan Zipursky, a specialist in clinical pharmacology and toxicology at Sunnybrook Health Sciences Centre in Toronto.

“That is a vital potential adversarial drug event that should be studied in a scientific way,” Zipursky said.

Health Canada said if its review confirmed any latest safety risks, it “will take appropriate motion and proceed to maintain Canadians informed.”

Janet Currie, a research collaborator with UBC’s school of nursing, has studied domperidone use amongst breastfeeding women and has spoken with several who struggled with psychiatric symptoms once they tried to quit.

Currie welcomed the Health Canada safety review, but said it’s “long overdue.”

She worries that breastfeeding women, doctors and midwives may not have guidance on what to do while the review takes place.

“My concern is how long it will take and what’s going to occur to moms who’re considering taking the drug, to prescribers and to those trying to scale back it within the meantime,” she said in an email on Tuesday.

But Newman, of the International Breastfeeding Centre, disagreed that there’s a necessity for Health Canada to conduct a security review.

“It could be a pity in the event that they restricted using domperidone,” he told The Canadian Press on Tuesday, noting that he’s been prescribing it for a long time.

“It helps moms to succeed at breastfeeding and we now have very, only a few unwanted effects with it.”

His clinic has at all times given nursing moms instructions on how you can wean off the drug slowly to forestall symptoms, Newman said.

“I actually have had the occasional mother who got here to me … or wrote me and said, ‘, I believe that I’m feeling somewhat bit unwell.’ (Then) I say, OK, return as much as the previous dose and we’ll go much more slowly,” he said.

“This drug shouldn’t be prescribed by individuals who don’t know anything about domperidone,” Newman said.

The FDA has banned the drug within the U.S. — even for its intended use to treat gastrointestinal disorders — due to concerns about potential cardiac unwanted effects.

“The risks of cardiac arrhythmias, cardiac arrest and sudden death outweigh any potential advantage of the unapproved use of domperidone in healthy lactating women,” the agency said in a press release to The Canadian Press earlier in January.

Health Canada also warns of potential cardiac unwanted effects on its information page about domperidone.

This report by The Canadian Press was first published Jan. 31, 2023.

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