Health Canada is reviewing the safety of controversial breastfeeding drug IG News

Health Canada has launched a safety review of psychological withdrawal symptoms associated with stopping or reducing the use of a commonly prescribed medication to help women breastfeed.

The agency confirmed the review in an email to CBC News.

“A safety review is underway for domperidone and drug withdrawal symptoms after stopping or reducing the dose of domperidone used to encourage lactation,” the statement said.

Domperidone is approved in Canada for the treatment of gastrointestinal disorders. Health Canada has never authorized its use as a lactation aid, but it is widely prescribed off-label for this purpose.

Here’s Health Canada’s review CBC News investigation Serious psychological effects that can occur when some women stop taking the drug. The women CBC spoke to reported anxiety, lack of sleep and thoughts of harming themselves so severe that in some cases they were unable to care for their children or return to work. A woman described several attempts to take her own life.

The CBC’s investigation also found that domperidone is prescribed by some doctors to stimulate lactation at doses three to five times higher than those recommended by both Health Canada and the drug’s manufacturer. Because it does not have 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 such as Health Canada to evaluate the safety of a drug for an off-label purpose, said Mina Tadrus, an assistant professor in the Leslie Dann Faculty of Pharmacy at the University of Toronto who specializes in drug safety.

“Maybe the company didn’t intend it for that, so the original clinical trials weren’t designed for that. And so that means they have to look at different mechanisms to be able to evaluate the safety of these drugs.” has to be seen.”

According to Tadars, this could include looking at data from other countries with large populations.

Case Study Document Concerns

However, there are case studies documenting the effects of withdrawal, including three published In the peer-reviewed journal Breastfeeding Medicine, November 2022. Domperidone blocks dopamine receptors in the brain, which stimulate the release of prolactin. This causes lactation, the authors note, but may also cause domperidone to act as an antipsychotic. The authors also noted that withdrawal symptoms are usually less severe when women taper off the drug gradually.

The most recent case studies are from the United States, where domperidone is not approved by the Food and Drug Administration for any purpose. A CBC investigation found that some American women get prescription drugs from doctors in Canada.

The statement said Health Canada would review “all relevant domestic and foreign case reports”.

The reviews may result in Health Canada requesting further information, studies or monitoring by the manufacturer. They may also issue warnings to patients and health care providers, change the way the drug is labeled or, if necessary, withdraw the drug from the market “if the benefits no longer outweigh the risks of the product,” according to the release issued by the department. Statement.

“The decision to take action, including issuing an alert, is not based solely on the number of case reports, but on a comprehensive assessment of the information contained in these case reports,” said the Health Canada statement.

“Should new security risks be confirmed, Health Canada will take appropriate action and will continue to inform Canadians.”

look | Women report dangerous effects of withdrawal after taking domperidone as a lactation aid:

The distinction between quantity and quality of reports is important, Tadrus said, because the large number of reports, especially from non-physicians, may indicate only that people believe there is an association between a drug and a reaction.

“That’s the lesson we’ve learned with vaccines, for example, where these adverse events have led to a flood of systems,” he said.

“And so if you base something just on the number of reports without doing a thorough investigation and without a different type of study design that minimizes bias … you may jump to the wrong conclusions.”

Health Canada has recently conducted several safety reviews of domperidone. 2021, Previous reviews confirmed an increased risk of serious abnormal heart rhythms and sudden cardiac death associated with the use of domperidone. As a result of these reviews, Health Canada began recommending a maximum daily dose of 30 mg and restricted its use in patients with certain cardiovascular conditions or on other medications.