其 他 安 全 警 示
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| Canada: Summary Safety Review: Amiodarone: Assessing the potential risk of primary graft dysfunction following heart transplantation (English only) |
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Health Canada announces that it reviewed the potential risk of primary graft dysfunction (PGD) following heart transplantation with the pre-transplant use of amiodarone. The safety review was triggered by a labelling update in the United Kingdom.
Health Canada reviewed information provided by the manufacturers, and from searches of the Canada Vigilance database and the scientific literature. At the time of the review, Health Canada had not received any Canadian reports of PGD related to the pre-heart transplant use of amiodarone. Health Canada reviewed 7 international cases of PGD in patients taking amiodarone before heart transplantation. In all 7 cases, the role of amiodarone could not be determined due to insufficient clinical information about factors that could have contributed to the risk of PGD, such as the use of other medications and patient medical conditions. Health Canada also reviewed 6 articles published in the scientific literature. While these studies had a number of weaknesses, including the presence of confounders (other factors that may have contributed to the occurrence of PGD) and bias (conscious or unconscious influencing of a study and its results), overall the evidence reviewed was sufficient to support an increased risk of PGD in patients taking amiodarone before heart transplantation.
Health Canada’s review found a possible link between the pre-heart transplant use of amiodarone and the risk of PGD. Health Canada will work with the manufacturers to update the Canadian Product Monograph of amiodarone-containing products to include the risk of PGD following heart transplantation.
Please refer to the following website in Health Canada for details:
http://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1706035839788
In Hong Kong, there are 8 registered pharmaceutical products containing amiodarone. All products are prescription-only medicines. So far, the Department of Health (DH) has received 2 cases of adverse drug reaction related to amiodarone, but these cases were not related to PGD. In light of the above Health Canada’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Thursday, Mar 28, 2024
Issued at HKT 17:00
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