Overview
- The MHRA announced on Thursday, October 15, 2026, that patient information leaflets will carry a new boxed warning, an electronic patient card will be issued immediately with hard-copy cards to follow, and some antidepressant leaflets will include the term Post SSRI Sexual Dysfunction (PSSD).
- Healthcare professionals are being asked to explain the risk of new or worsening suicidal thoughts when starting or changing antidepressant doses and to signpost urgent help while reporting suspected reactions through the Yellow Card scheme.
- The regulator says a safety (ancillary) leaflet giving more detailed benefits, risks and alternatives will be developed with NHS partners and is expected to be available in 2027 as part of systemwide updates to NICE guidance and prescribing resources.
- The changes follow a CHM Expert Working Group review that ran from May 2024 to July 2025, used patient and family testimony to shape wording, and led the CHM to advise stronger, consistently phrased warnings in September 2025.
- MHRA and clinicians stress that antidepressants remain effective for many patients and warn people not to stop medicines without medical advice, while noting that some doctors dispute whether persistent sexual problems are caused by the drugs or by underlying conditions.