Health Canada has released a safety review of psychological withdrawal symptoms associated with stopping or reducing the use of a commonly prescribed drug to help women breastfeed.
The agency confirmed the review in an email to CBC News.
“A safety review is currently underway for domperidone and drug withdrawal symptoms after discontinuing 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 licensed its use as a lactation aid, but it is widely prescribed off-label for this purpose.
Health Canada’s review follows a CBC News investigation in 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 unable to care for their children or return to work. One woman described multiple attempts to take her own life.
The CBC investigation also found that some doctors prescribe domperidone to stimulate lactation in doses three to five times higher than those recommended by both Health Canada and the drug’s 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 assess the safety of a drug for an off-label purpose, said Mina Tadrous, an assistant professor at the University of Toronto Leslie Dan School of Pharmacy who specializes in drug safety. medicines.
“The company may not have designed it for that, so the original clinical trials weren’t designed for that. And that means they have to look at different mechanisms to be able to assess the safety of these drugs,” he said.
That may include looking at data from other countries with larger populations, according to Tadrous.
Case studies document concerns
However, there are case studies documenting the effects of withdrawal, 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 it can also cause domperidone to act as an antipsychotic. The authors also noted that withdrawal symptoms tend to be 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. The CBC investigation found that some American women get the drug from doctors in Canada.
Health Canada will review “all relevant domestic and foreign case reports,” the statement said.
Revisions may result in Health Canada requesting further information, studies or monitoring from the manufacturer. They can also result in warnings to patients and health care providers, changes to the way a drug is labeled 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 issued 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 evaluation of the information contained in these case reports,” the Health Canada statement said.
“If new security risks are confirmed, Health Canada will take appropriate action and continue to keep Canadians informed.”
CLOCK | Women report alarming withdrawal effects after taking domperidone as a lactation aid:
WARNING: This story contains distressing details about suicidal thoughts and attempts. Correction: An earlier version of this video included inaccurate data from Health Canada on the number of domperidone prescriptions 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 the quantity and quality of reports is important, Tadrous said, because a large number of reports, especially from non-physicians, can only indicate that people believe there is 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 swamped,” he said.
“So if you base something just on the number of reports without doing extensive research and a different type of study design that reduces bias…you could come to a false conclusion.”
Health Canada has conducted multiple safety reviews of domperidone, the most recent in 2021. Previous reviews confirmed the risk of serious abnormal heart rhythms and sudden cardiac death related to the use of domperidone. These revisions resulted in Health Canada introducing a maximum daily dose recommendation of 30 mg and restricting its use in patients with certain heart conditions or taking other medications.
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