Antidepressant information leaflets are being strengthened with a prominent warning about suicidal thoughts and behaviour, while patients will also receive a portable card highlighting key safety messages. The changes follow a review of how these risks and the possibility of persistent sexual dysfunction are explained.
The warnings clarify existing risks rather than identify newly discovered ones. The aim is to make existing information clearer and easier to find. Revised leaflets will include a boxed warning, signposting to sources of urgent help. The card is intended to reinforce the messages in a format that can be kept with a patient.
What the changes include
The card is expected to be available digitally and in hard copy. An electronic version can be used as an interim measure before printed cards become available. A separate safety leaflet is being developed with health-service partners and is expected in 2027. It will set out treatment benefits, risks and alternatives to support conversations between patients and healthcare professionals.
Leaflets for some antidepressants will also use the term “post SSRI sexual dysfunction”, or PSSD, where symptoms may continue after treatment ends. The updated wording explains that some people experience persistent sexual side-effects and that more research is needed to understand why this happens and how common it is. The regulator’s product information identifies ten medicines for revised wording on sexual dysfunction: citalopram, escitalopram, duloxetine, fluvoxamine, fluoxetine, paroxetine, sertraline, venlafaxine, amitriptyline and nortriptyline.
The measures cover antidepressant medicines broadly, while the PSSD wording applies to specified products. The revised patient information is being developed through feedback from patients with a range of mental health conditions. A focus group convened with the Patients Association helped refine its wording and format.
Advice during treatment
Healthcare professionals are advised to discuss suicidal thoughts and behaviour when a patient starts an antidepressant, changes dose or attends a review. They should also discuss the possibility of sexual dysfunction, including symptoms that may continue after stopping certain medicines, and monitor patients regularly in line with clinical guidance.
Patients who develop new or worsening suicidal thoughts, particularly after starting treatment or changing dose, are advised to seek urgent medical help. The safety information directs people to NHS 111, a local mental health crisis team or other support. Anyone concerned about sexual side-effects is advised to contact a healthcare professional.
Patients are specifically advised not to stop an antidepressant without first speaking to a healthcare professional. Antidepressants remain important treatments; the changes are intended to clarify existing risks, not signal newly discovered effects.
The review began after patients and families raised concerns about whether existing leaflets adequately explained suicidal thoughts and behaviour and sexual symptoms that may persist after treatment. An expert working group met from May 2024 to July 2025; its recommendations were considered by the Commission on Human Medicines in September 2025. The regulator is also coordinating work with health-system organisations on consistent safety messages in clinical guidance. The impact of leaflet changes and the patient card is expected to be monitored through manufacturer risk-management plans and a study using primary-care data.
