其 他 安 全 警 示
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| Canada: Summary Safety Review: Domperidone: Assessing the potential risks of serious ventricular arrhythmias, QT interval prolongation and sudden cardiac death (English only) |
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Health Canada announces that it carried out a follow-up safety review of domperidone and serious ventricular arrhythmia, QT interval prolongation and sudden cardiac death in 2021 to one previously completed in 2014. This latest safety review was triggered by the publication of a Canadian study on the risk of heart effects with domperidone when used for lactation promotion, an off-label use in Canada. The purpose of the current review was to consider recent information, for both the approved and off-label use, and determine if additional measures were warranted.
Health Canada reviewed the available information from searches of the Canada Vigilance database and published literature for both the approved and off-label use of domperidone. Health Canada reviewed 15 cases (8 Canadian and 7 international) of serious ventricular arrhythmia, QT interval prolongation, and/or sudden cardiac death/cardiac arrest following the use of domperidone for both the approved and off-label use. Of the 15 cases, 6 (3 Canadian) were found to have a possible link with domperidone use. The remaining 9 cases (3 Canadian) did not have enough information to be further assessed.
The Canadian study that triggered this review found that the risk of cardiac side effects is very low in individuals using domperidone off-label to promote lactation. Health Canada's safety review also looked at the scientific literature published since 2014, and did not find any new information about serious ventricular arrhythmia, QT interval prolongation, or sudden cardiac death following the use of domperidone for both the approved and off-label use.
Health Canada's review of the available information found no new safety information related to the risks of serious ventricular arrhythmia, QT interval prolongation or sudden cardiac death for both the approved and off-label use of domperidone. As a result, no further updates to the Canadian Product Monographs are warranted.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00277
In Hong Kong, there are 41 registered pharmaceutical products containing domperidone. All products are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to domperidone.
News related to risk of serious cardiac adverse drug reactions associated with the use of domperidone was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 8 Mar 2012, with the latest update posted on 17 Dec 2019. Letters to inform local healthcare professionals were issued by the DH on 8 Mar 2012, 10 Mar 2014, 19 Apr 2016 and 17 Dec 2019. In Feb 2012, May 2014 and Jun 2020, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and decided that the sales pack label and/or package insert of domperidone-containing products should include safety information related to cardiovascular risks. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Friday, Dec 31, 2021
Issued at HKT 15:00
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