其 他 安 全 警 示
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| Canada: Summary Safety Review - Proscar and Propecia (finasteride) - Assessing the potential risk of suicidal thoughts and/or behaviour (suicidal ideation) (English Only) |
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Health Canada announces that it reviewed the potential risk of suicidal ideation with use of Proscar or Propecia (finasteride) due to reported cases of suicidal ideation and self-injury received in Canada and internationally. The cases led to the investigation of the possible relationship between finasteride use and suicidal ideation through a number of assessments.
The topic of finasteride and suicide/self-injury has been monitored on an ongoing basis by Health Canada since 2011. A first safety review was completed in 2012, and it was recommended that the topic be re-assessed in 2 years. A second safety review was completed in 2014, where the information at that time could not confirm if there was a link or not between finasteride use and suicide/self-injury. It was recommended as a precautionary measure to inform physicians of the potential risk and assess the topic again after another 2 years. As a result of this recommendation and reported cases, Health Canada began this safety review.
At the time of the review, Health Canada had received 26 Canadian reports of events related to suicide or self-injury with the use of finasteride. Between 2012 and 2016, the Canadian reporting rate for finasteride and suicide/self-injury-related events increased by 2.5 times. In the assessment of the Canadian reports, a cause and effect relationship could not be confirmed or denied, and as a result, a link between finasteride and suicide/self-injury-related events was deemed possible. A search in the World Health Organization's Adverse Drug Reaction Database found 368 international reports of suicide/self-injury-related events reported in patients treated with finasteride, up to 16 Sep 2018. There were 5 studies reviewed that were published between 2015-2018 on finasteride and suicide-related events. These publications support a link between finasteride use and the risk of suicidal ideation. The international reports, literature, and regulatory information that were reviewed could neither confirm nor deny a cause and effect relationship between finasteride and suicide/ self-injury.
Health Canada's review concluded that there may be a link between Proscar and Propecia (finasteride) and the risk of suicidal ideation. Health Canada has notified the manufacturer to update the Canadian product information to include a warning on this potential safety issue.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00218
In Hong Kong, there are 38 registered pharmaceutical products containing finasteride, and all products are prescription-only medicines. So far, the Department of Health (DH) has received one case of adverse drug reaction related to finasteride, but this case is not related to suicidal ideation. Related news was previously issued by the United Kingdom Medicines and Healthcare products Regulatory Agency, and was posted on the Drug Office website on 25 May 2017. Letters to inform local healthcare professionals were issued by DH on the same day. In Sep 2017, the Registration Committee of the Pharmacy and Poisons Board discussed the matter, and decided that the sales pack labels and/or package inserts of finasteride-containing products should include warnings on suicidal ideation. DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Wednesday, Feb 27, 2019
Issued at HKT 15:00
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