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Drug Safety Update: Improved communication of suicidal behaviour and persistent sexual dysfunction risks of antidepressants

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New safety measures are now being implemented for all patients taking antidepressant medications. This follows a detailed review, involving patients and their families, into how the risks of suicidal thoughts and behaviours, and persistent sexual dysfunction are communicated in the patient information leaflets (PILs) that accompany antidepressant medications. These changes involve: 

  • a new boxed warning in PILs
  • a new patient information card (in digital and hard copy format)
  • a supporting safety (ancillary) leaflet
  • inclusion of the term Post-SSRI Sexual Dysfunction (PSSD) in relevant patient information for some antidepressants. 

Please refer to the full MHRA Drug Safety Update and associated patient materials for complete details of advice for healthcare professionals and patients.

Expiry date: Sunday, 27 December 2026