PharmacovigilanceGuideline · final

MHRA updates antidepressant guidance after review of suicidality and persistent sexual dysfunction communication

🇬🇧 MHRA · Thu 15 Oct 2026

The UK regulator has revised its 2014 SSRI and SNRI safety page to reflect a review of how certain risks are explained to patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance page on antidepressants on 15 October 2026. The page, first published on 18 December 2014, covers the use and side effects of selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs).

According to the update note, the changes reflect the outcome of an MHRA review of antidepressants. The review looked at how two risks are communicated to patients: suicidal thoughts and behaviours, and sexual dysfunction where symptoms continue after treatment has stopped.

The guidance is aimed at healthcare professionals. It lists risk of suicidal behaviour, withdrawal reactions, use in pregnancy, effects on tamoxifen effectiveness and interaction with methylthioninium chloride as its topics.

The page itself does not set out the detailed wording changes. It directs readers to the Summary of Product Characteristics and Patient Information Leaflet for each medicine, available through the MHRA's products page, for up-to-date information.

What it means for your team

  • Marketing authorisation holders for SSRIs and SNRIs in the UK should check the MHRA products page for any changes to product information and patient leaflets arising from the review.
  • Pharmacovigilance teams should note the focus on suicidal thoughts and behaviours and on sexual dysfunction that persists after stopping treatment when reviewing risk communication materials.
  • The summary page does not detail the specific changes, so teams will need to consult the current Summaries of Product Characteristics and leaflets directly.

Official guideline text: MHRA ↗

Article written by VigiEye from the official source (MHRA). AI-assisted; check the source before acting.

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