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The Ministry of Health of Canada (Health Canada) has published a safety review of medicinal products containing finasteride (Finasteride)

16.03.2023 967 views

This review is intended primarily for healthcare professionals. It provides a brief summary of key information on the safety of medicinal products published in January 2023 by the Ministry of Health of Canada (Health Canada). The published information is not exhaustive.

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information, as well as what is known about the use of medicinal products both in Canada and abroad.

New safety information on medicinal products

Medicinal products containing finasteride – Assessment of potential risks of suicide, suicidal ideation (suicidal thinking) and self-harm

This safety review assessed the risk of suicide, suicidal ideation, and self-harm associated with the use of medicinal products containing finasteride. The analysis of available information conducted by Health Canada identified a possible link between the use of finasteride and the risk of suicidal ideation and self-harm. There is currently insufficient information to establish a link between the use of finasteride and the risk of suicide. Health Canada is working with registration certificate holders to update the instructions for medical use for medicinal products containing finasteride in order to strengthen warnings about the risks of suicidal ideation and self-harm, as well as to include information on screening patients for psychiatric risk factors before starting treatment, and on continuous monitoring of patients during and after discontinuation of treatment.

The original text of this publication can be found at the link:

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