Health Canada Conducts Safety Review of Breastfeeding Medication Domperidone

Health Canada is conducting a safety review of domperidone, a drug often prescribed off-label to breastfeeding mothers as a way to increase their milk supply.

A Health Canada spokesperson told the Epoch Times in an email that it was “actively” monitoring the safety of domperidone maleate.

A safety review of the drug will begin in December 2022 and is not expected to be completed until the summer of 2023. A spokesperson said it was used to stimulate lactation.

This drug has been approved for use in Canada since 1985. It is usually prescribed for the management of gastrointestinal disorders such as gastritis and diabetic conditions. It is also used to prevent nausea and vomiting caused by other drugs.

Domperidone acts as a dopamine 2 antagonist. paper Published in the Journal Breastfeeding Medicine December 2022.

The paper reported on three Americans who used domperidone to help with breastfeeding and experienced “varying degrees of psychiatric withdrawal symptoms that lasted for months” when their dose was reduced and they finally stopped taking the drug. A patient was cited.

The authors noted that this occurred in the same time frame that women could experience symptoms of postpartum depression. suggested that the dose be tapered slowly.

Health Canada uses, in safety reviews, manufacturers’ reports, adverse reaction reports from health professionals and consumers, academic research, surveillance, and studies available in Canada and abroad to assess the safety risks of medicines. He said he would look into other data.

Regulators will also consider the severity and frequency of adverse events, other products that can treat the same condition, and the patient population typically prescribed.

A December 2022 CBC News report found that some women in Canada experienced a range of symptoms including depression, severe anxiety, intrusive and disturbing thoughts, and insomnia when they stopped taking the drug. said he did.

US ban

Domperidone is forbidden In the United States, it has been associated with fatal arrhythmias in cancer patients who took the drug to combat nausea and vomiting.

Canadian Breastfeeding Expert Dr. Jack Newman, 2019 Recommendation The decision to ban domperidone was based on “very high doses” of domperidone administered intravenously every few hours.

According to Health Canada, domperidone has never been approved for lactating women in Canada, but it may improve lactation and facilitate milk supply in new mothers, primarily by stimulating the production of prolactin. It is prescribed off-label because it is known as a lactation stimulant, which means

Health Canada previously warned that domperidone carries the risk of potential cardiac events, including adverse reactions, arrhythmias, and death, and warned physicians not to exceed the recommended daily dose of 30 mg.