Health Canada reviewing FDA-banned breastfeeding drug: What is domperidone?
Health Canada to conduct a safety review of domperidone following reports of severe psychological withdrawal symptoms.
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Health Canada is reviewing the safety of domperidone, an off-label breastfeeding aid, following reports that some mothers have experienced severe psychological symptoms when they tried to stop taking the drug.
"The safety review, which started 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 statement on Tuesday.
The prescription drug, which is not authorized by Health Canada for lactation promotion, has been linked to reports of depression, anxiety, insomnia and other psychological symptoms.
What is domperidone?
Domperidone is approved in Canada for treating gastrointestinal symptoms but is routinely prescribed to women as an off-label lactation aid.
When used as a breastfeeding aid, care providers often prescribe domperidone in higher doses than the 30 mg a day approved by Health Canada for gastrointestinal symptoms.
Why is domperidone controversial?
While Health Canada has not authorized domperidone products for milk supply, that's not why the drug is making headlines.
Off-label uses of prescription medications are common practice in Canada. One study found that 11 per cent of drugs are routinely prescribed for off-label purposes in the adult population. For pediatric patients, the study found that up to 75 per cent of drugs are used for off-label purposes.
Health Canada is reviewing the safety of domperidone because of reports that some mothers in Canada and the U.S. have experienced severe psychological withdrawal symptoms when they stopped taking it.
Potential psychiatric concerns
A CBC News investigation reported cases of women experiencing severe anxiety, depression, intrusive thoughts and insomnia when they tried to stop taking domperidone.
The investigation found that some doctors prescribe domperidone at doses three to five times higher than its recommended dosage by the drug manufacturer and Health Canada.
Because the increased dosage and its off-label use as a lactation aid are not approved anywhere in the world, no large-scale clinical trials shed light on its possible psychological side effects.
Domperidone is associated with potential cardiac risks, including sudden cardiac death, according to Health Canada. The agency issued two safety alerts about domperidone and the risk of "serious abnormal heart rhythms and sudden death (cardiac arrest)" in 2012 and 2015.
In the U.S., the FDA banned the drug — even for its intended use to treat gastrointestinal disorders — because of concerns about potential cardiac arrhythmias, cardiac arrest and sudden death in patients receiving an IV form of domperidone.
Health Canada to review reports
Domperidone has been prescribed for decades as a breastfeeding aid among postpartum women.
In light of its potential psychological side effects, Health Canada will review "all relevant domestic and foreign case reports" related to the drug.
Health Canada will "continue to monitor the safety of domperidone, as it does for all health products on the Canadian market, to identify and assess potential harms," the health authority said.
"Health Canada will take appropriate and timely action should new health risks be identified."
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