Health Canada warns about Persistent Sexual Dysfunction after SSRIs & SNRIs

Health Canada has just concluded its review of persistent sexual dysfunction after stopping SSRIs and SNRIs. Let’s look at some of the background.

January 2019

On 25 January 2019, we were contacted by the Marketed Pharmaceuticals and Medical Devices Bureau at Health Canada. They had become aware of our 2018 paper, “Enduring sexual dysfunction after treatment with antidepressants, 5α-reductase inhibitors and isotretinoin: 300 cases” as well as our petition, “Sexual side effects of SSRIs and SNRIs”, which was filed with FDA and the European Medicines Agency (EMA).

Health Canada informed us that they were assessing the potential risk of post-treatment sexual dysfunction associated with the use of SSRIs/SNRIs and would like additional data if possible.

They asked for anonymized patient data collected by RxISK, and a copy of the letter from Dr. A Nathwani (Chief Medical Officer/ Global Head of Medical Function / Executive Vice President of Sanofi) which was cited in the petition.

We provided them with a package of data comprising:

• A spreadsheet containing 298 anonymised RxISK Reports of post-treatment sexual dysfunction linked to serotonin reuptake inhibitors.
• A copy of the letter from Dr. A Nathwani.
• With permission, 69 named reports, 32 of which included accompanying letters from healthcare professionals.

They acknowledged receipt but provided no further response.

March 2020

On 4 March 2020, we wrote to Health Canada again. Our letter addressed several points including:

• Those who had provided named reports had done so on the basis that they were making a positive contribution to a serious health issue, and therefore the lack of any communication or action was disappointing.
• The continued lack of warnings about persistent sexual dysfunction was undoubtedly contributing to some of the dismissive responses that patients were receiving when trying to report the problem to healthcare professionals.
• We drew attention to the issue of genital anesthesia, well described in the literature, both on treatment and as part of post-SSRI sexual dysfunction (PSSD). We noted that EMA had failed to address this issue as part of their new warnings.

You can read the letter here. It was sent to Health Canada by email and post, but we received no acknowledgement.

January 2021

A member of the PSSD community made us aware of an announcement from Health Canada, dated 6 January 2021. The review of persistent sexual dysfunction after stopping SSRIs and SNRIs is now concluded and a summary of the findings is available at the following link:

https://hpr-rps.hres.ca/reg-content/summary-safety-review-detail.php?lang=en&linkID=SSR00254

The announcement states that:

“Health Canada will work with manufacturers to update the product safety information for all SSRIs and SNRIs to recommend that healthcare professionals inform patients about the potential risk of long lasting (possibly weeks to years) sexual dysfunction despite discontinuation of SSRIs or SNRIs.”

At the time of writing this blog post, there’s no indication of the proposed wording for the new warning.

In terms of FDA, our petitions for sexual side effects of SSRIs & SNRIs and sexual side effects of isotretinoin are still lodged within the official Citizen Petition process.