PRAC recommendations on signals adopted at the 13-16 May 2019 PRAC meeting, section 1.3: SNRIs and SSRIs - persistent…
European regulators require a label warning that sexual side effects can persist after stopping an SSRI or SNRI — how would you and I tell that apart from the depression itself if it happened to me?
Well-supported by good-quality research. how we score evidence
Caveat on this rating: A regulatory label change is a precautionary act on a safety signal, not proof of incidence, causation, or permanence. The evidence base the PRAC weighed was EudraVigilance reports, literature, social media, and manufacturer reviews. Clomipramine and vortioxetine were part of the same signal assessment but were explicitly not covered by the labelling recommendation. US FDA labelling does not carry equivalent wording.
On 16 May 2019 the EU drug regulator's safety committee ordered every manufacturer of citalopram, escitalopram, fluvoxamine, fluoxetine, paroxetine, sertraline, duloxetine, venlafaxine, desvenlafaxine, and milnacipran to add this warning within two months: "There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI." The patient leaflet wording is "In some cases, these symptoms have continued after stopping treatment." This is a regulator acting on case reports and pharmacovigilance data, not a prevalence study — how often it happens is still unknown, and that uncertainty cuts both ways.
Worth asking
European regulators require a label warning that sexual side effects can persist after stopping an SSRI or SNRI — how would you and I tell that apart from the depression itself if it happened to me?
What to watch for
Evidence quality tells you whether to trust the finding — not whether the treatment is safe. These are the risks this research reports.
- Persistent sexual dysfunction (PSSD)
- Sexual side effects
Source
PRAC recommendations on signals adopted at the 13-16 May 2019 PRAC meeting, section 1.3: SNRIs and SSRIs - persistent sexual dysfunction after drug withdrawal (EMA/PRAC/265212/2019). — Pharmacovigilance Risk Assessment Committee (PRAC), European Medicines Agency. Rapporteur: Gross-Martirosyan L. (2019)
Regulator or national health body
How this was scored
- Study design
- Regulatory safety determination
- Funding
- Funding not disclosed
- Published in
- Regulator or national health body
- Sample size
- not recorded
- Preregistered
- No
- Conflicts disclosed
- No
- Independent of proponent
- Yes
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published August 19, 2026.
Questions
How strong is the evidence behind this?
Resolv rates this source "strong evidence". Well-supported by good-quality research. It scores 70 out of 100 on our published rubric. One caveat travels with that badge: A regulatory label change is a precautionary act on a safety signal, not proof of incidence, causation, or permanence. The evidence base the PRAC weighed was EudraVigilance reports, literature, social media, and manufacturer reviews. Clomipramine and vortioxetine were part of the same signal assessment but were explicitly not covered by the labelling recommendation. US FDA labelling does not carry equivalent wording. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
PRAC recommendations on signals adopted at the 13-16 May 2019 PRAC meeting, section 1.3: SNRIs and SSRIs - persistent sexual dysfunction after drug withdrawal (EMA/PRAC/265212/2019). — Pharmacovigilance Risk Assessment Committee (PRAC), European Medicines Agency. Rapporteur: Gross-Martirosyan L. (2019). Published in: Regulator or national health body. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Regulatory safety determination. Funding: Funding not disclosed. The researchers were independent of whoever benefits from the result. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.