Health Canada has just concluded its review of persistent sexual dysfunction after stopping SSRIs and SNRIs. Let’s look at some of the background.
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:
They acknowledged receipt but provided no further response.
On 4 March 2020, we wrote to Health Canada again. Our letter addressed several points including:
You can read the letter here. It was sent to Health Canada by email and post, but we received no acknowledgement.
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:
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.