MHRA Safety Roundup: October 2026

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Antidepressants: new safety measures for all patients to improve communication of the risk of suicidal thoughts and behaviours and persistent sexual dysfunction

New safety measures are now being implemented for all patients taking antidepressant medications. This follows completion of 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 the PIL, a new patient card, and a supporting safety (ancillary) leaflet. The term post SSRI sexual dysfunction (“PSSD”) is also being added to the PIL for some antidepressant medications.

Key Advice for Healthcare Professionals:

discuss with patients when starting or changing the dose of an antidepressant or at their next review, the risk of suicidal thoughts and behaviours. Advise patients to seek urgent medical attention if they experience new or worsening feelings of suicidal intent in relation to starting an antidepressant, especially early in treatment or following dose changes  

discuss with patients when starting or changing the dose of an antidepressant, or at their next review, that there is evidence that some antidepressants are associated with a risk of sexual dysfunction and that symptoms may continue after stopping treatment with certain antidepressants. Some patients refer to this as “PSSD”  

follow the relevant NICE guidance and monitor your patients regularly after starting treatment with an antidepressant  

give your patient the safety (ancillary) leaflet when it becomes available in 2027 to support your risks and benefits discussions