MHRA updates antidepressant leaflets with boxed warnings and PSSD term

SHOTS Desk · Thu · 15 Oct 2026 · 14:41 · Reported

The Medicines and Healthcare products Regulatory Agency is introducing new measures to strengthen how risks associated with antidepressants are communicated to patients, carers and healthcare professionals.

The changes follow a review by the Commission on Human Medicines, prompted by concerns from patients and families about how information on suicidal thoughts and behaviours, and persistent sexual dysfunction after stopping treatment, is presented in patient information leaflets.

Leaflets will be updated to include a boxed warning signposting information on suicidal thoughts and behaviours. Leaflets for certain antidepressants will also include the term Post SSRI Sexual Dysfunction to reflect the risk of symptoms continuing after treatment ends.

A patient card reinforcing key safety messages is expected to be included in or on the medicine box. A supporting safety leaflet, to be given to patients at their first appointment discussing antidepressants and to those already receiving t

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