Regulatory documentVerifiedLiterature sweep · Oct 2026

Summary Safety Review — Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-norepinephrine Reuptake Inhibitors (SNRIs): Assessing the Potential Risk of Sexual Dysfunction despite Treatment Discontinuation

Health Canada

Health Canada Drug Product Vigilance (dhpp.hpfb-dgpsa.ca), resource SSR002542021-01

Summary (paraphrased)

Health Canada's published review of whether SSRI/SNRI sexual dysfunction can persist, worsen, or newly appear after stopping treatment. Its case review found 58 sexual-dysfunction reports, of which 43 (16 Canadian, 27 international) were judged possibly linked to prior SSRI/SNRI use and discontinuation, with symptoms lasting weeks to years in some cases. The review could neither confirm nor rule out a causal link, but Health Canada committed to work with manufacturers so that all SSRI/SNRI product monographs advise informing patients about the potential risk of long-lasting sexual symptoms persisting after stopping treatment, and published a Health Product InfoWatch label-update notice in December 2021.

Why it’s in the corpus

Canada's counterpart to the EMA 2019 action and the document behind the Canadian label warnings. Distinct from the corpus's existing timeline event noting its publication — this is the review itself, with the 43 possibly-linked cases and the exact "weeks to years" wording.

Details

Record ID: LIT-071
Catalog no.: #391
Type: Regulatory document
Collection: Literature sweep · Oct 2026
Study type: n/a — regulatory
Sample size: n/a
Journal / site: Health Canada Drug Product Vigilance (dhpp.hpfb-dgpsa.ca), resource SSR00254
Published: 2021-01
Sweep axis: regulatory
Sweep date: 2026-10-07
Sweep record: LIT-E-007
Verification: verified — official Health Canada URL identified via search index (direct fetch timed out); content corroborated by the official House of Commons petition-response page (ourcommons.ca, Petition 441-00192) which reproduces the review's conclusions and actions
Quality notes: The review's conclusion is deliberately non-committal on causality; the labelling action is the substantive outcome. Note the corpus already has a timeline event about this publication — keep both, document vs. event.

Topics

PSSD

Keywords

Health Canada Summary Safety Review SSRIs SNRIs persistent sexual dysfunction PSSD product monograph labelling

Cite

Health Canada. Summary Safety Review — Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-norepinephrine Reuptake Inhibitors (SNRIs): Assessing the Potential Risk of Sexual Dysfunction despite Treatment Discontinuation. Health Canada Drug Product Vigilance (dhpp.hpfb-dgpsa.ca), resource SSR00254. 2021.

Gray literature
Seven drug regulators, including the EU, UK, and Canada, have warned since 2019 that antidepressant-linked sexual side effects can persist for years after the drug is stopped. The US hasn't.
ScienceBlog (Lab Report column) · scienceblog.com
A 2026 news-analysis piece mapping how seven regulators addressed persistent post-antidepressant sexual dysfunction between 2019 and 2025: the EMA's 2019 PRAC conclusion and label changes, the UK's 2019 label-level implementation, Health Canada's 2021 safety…
LIT-0762026-08PSSDLiterature sweep · Oct 2026
Regulatory document
Re: Docket No. FDA-2017-P-5787 — Response to the Post-Finasteride Syndrome Foundation citizen petition
U.S. Food and Drug Administration (FDA) · FDA (letter to PFS Foundation, hosted as PDF on citizen.org)
FDA's 2022 decision letter on the PFS Foundation's 2017 citizen petition asking for withdrawal of Propecia 1 mg or stronger labelling. The agency denied the petition in part and granted it in part. It recounts the 2010–2012 labelling history (depression added…
LIT-0722022-06-08PFSLiterature sweep · Oct 2026

Summary (paraphrased)

Details

Record ID

LIT-071

Catalog no.

#391

Type

Regulatory document

Collection

Literature sweep · Oct 2026

Study type

n/a — regulatory

Sample size

n/a

Journal / site

Health Canada Drug Product Vigilance (dhpp.hpfb-dgpsa.ca), resource SSR00254

Published

2021-01

Sweep axis

regulatory

Sweep date

2026-10-07

Sweep record

LIT-E-007

Verification

verified — official Health Canada URL identified via search index (direct fetch timed out); content corroborated by the official House of Commons petition-response page (ourcommons.ca, Petition 441-00192) which reproduces the review's conclusions and actions

Quality notes

The review's conclusion is deliberately non-committal on causality; the labelling action is the substantive outcome. Note the corpus already has a timeline event about this publication — keep both, document vs. event.

Topics

PSSD

Related records

Gray literature

Seven drug regulators, including the EU, UK, and Canada, have warned since 2019 that antidepressant-linked sexual side effects can persist for years after the drug is stopped. The US hasn't.

ScienceBlog (Lab Report column) · scienceblog.com

A 2026 news-analysis piece mapping how seven regulators addressed persistent post-antidepressant sexual dysfunction between 2019 and 2025: the EMA's 2019 PRAC conclusion and label changes, the UK's 2019 label-level implementation, Health Canada's 2021 safety…

LIT-0762026-08PSSDLiterature sweep · Oct 2026

Regulatory document

Re: Docket No. FDA-2017-P-5787 — Response to the Post-Finasteride Syndrome Foundation citizen petition

U.S. Food and Drug Administration (FDA) · FDA (letter to PFS Foundation, hosted as PDF on citizen.org)

FDA's 2022 decision letter on the PFS Foundation's 2017 citizen petition asking for withdrawal of Propecia 1 mg or stronger labelling. The agency denied the petition in part and granted it in part. It recounts the 2010–2012 labelling history (depression added…

LIT-0722022-06-08PFSLiterature sweep · Oct 2026