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Sexuality is a vital part of identity, social participation, and physical, mental, and emotional well-being, and impairment in normal sexual function can significantly impact quality of life. Health Canada engages in ongoing efforts to address shame and stigma around sexuality and to raise public awareness of sexual health concerns.

In 2020, Health Canada assessed the potential risk of persistent or worsening sexual dysfunction, as well as the appearance of new symptoms of sexual dysfunction, after stopping treatment with selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs). The Summary Safety Review of this assessment was published in January 2021.

Following Health Canada’s review of published and unpublished population-based studies, as well as case reports of individual patients, it was decided not to include further detail in the product monograph (PM) about any particular symptom. Instead, it was recommended that PMs of SSRIs and SNRIs marketed in Canada be updated with the caution that patients be informed that there have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs or SNRIs. This labelling revision arising from Health Canada’s assessment is similar to the labelling changes implemented by the European Medicines Agency following their review.

Health Canada continues to work with the Manufacturers of SSRI and SNRIs to implement updates to the Product Monographs regarding sexual dysfunction. Additionally, a PM update notification was published in Health Canada’s Health Product Infowatch in December 2021 to inform healthcare professionals and Canadians that PMs of SSRIs and SNRIs have been, or will be, updated with new safety information recommending that patients be informed that there have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs and SNRIs.

In the Summary Safety Review on SSRIs and SNRIs published in January 2021, Health Canada included the adverse event reporting information that reads: “Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of SSRIs and SNRIs and other health products to the Canada Vigilance Program.”

In addition, Health Canada promotes adverse reaction reporting to Canadians, through the Government of Canada’s website, the monthly newsletter Health Product InfoWatch, the Canada Vigilance Program engagement events and other communications opportunities, to provide information about reporting and tools for health professionals and consumers to help them report. The department also makes adverse event reporting accessible through various means; reporting can be done online, by phone, or by submitting the Side Effect Reporting Form by fax or mail. 

Health Canada continues to monitor the safety of drug products available on the Canadian market. New evidence regarding adverse events published in the literature, reported by drug manufacturers, identified by international regulators, or captured through reports in the Canada Vigilance database is considered regularly by Health Canada through ongoing signal detection activities.

During the 2020 assessment, Health Canada considered the option of future research to better characterize the risk and minimize associated uncertainty. Health Canada has consulted with academic experts from the Drug Safety and Effectiveness Network (DSEN) on options for future research to better characterize the risk of persistent or worsening sexual dysfunction, as well as the appearance of new symptoms of sexual dysfunction with the use of SSRIs. Following discussions, it was determined that it would be challenging to design an observational study that could produce valid, consistent and robust results for a number of reasons, including the following challenges:

• Sexual dysfunction is itself a symptom of depression, making it harder to determine whether it is caused by the condition or by the treatment.
• It is also difficult to measure sexual dysfunction due to the various ways in which people may describe the symptoms, depending on the questions being asked.
• Finally, it is challenging to measure symptoms associated with drug discontinuation, since it is difficult to determine the time between stopping a drug and noticing an effect in the real-world data, and because there can be multiple unique causes of stopping drug treatment that would need to be accounted for.

All these factors contributed to the conclusion that it would be difficult to design an observational study that would provide reliable answers to this clinical question.

The Government of Canada recognizes that all Canadians should have access to a full suite of sexual and reproductive health resources and services. Budget 2021 provided $45 million over three years, as of April 2021, to improve access to sexual and reproductive health care support, information, and services. This funding will be provided primarily to community-based organizations addressing barriers to excellent sexual and reproductive health, including additional training and supports for physicians, culturally safe and inclusive sexual health education materials, and initiatives aimed at reducing shame and stigma around sexuality and sexual health. Through this funding, the Government strives to make sexual and reproductive health information and services more accessible for populations experiencing the highest risks and greatest barriers in relation to sexual and reproductive health, including women, youth, LGBTQ2IA people, Indigenous populations, and racialized Canadians.

There are currently no existing resources that collect comprehensive data on a wide range of sexual and reproductive health indicators in Canada, limiting the Federal Government’s ability to provide targeted supports. To address this challenge, $7.6 million has been provided over five years, starting in April 2021, for Statistics Canada to develop and implement a national survey on sexual and reproductive health. Better information will help ensure governments understand the challenges and improve the support they provide.

These important financial commitments will enable the Government of Canada to better understand the sexual and reproductive health issues facing Canadians, and to provide support to those who are experiencing barriers to sexual health and well-being.