Patient and family experiences inform antidepressant safety information review
Source: gov.uk (2025-12-01)

An Expert Working Group has completed a review into how the potential risks associated with antidepressant medicines are communicated to patients

An Expert Working Group (EWG) of the Commission on Human Medicines (CHM), advising the Medicines and Healthcare Products Regulatory Agency (MHRA), has concluded a detailed review into how the potential risks associated with 28 antidepressant medicines are communicated to patients within the Patient Information Leaflet (PIL).

The review was launched after concerns were raised by families and patients that current safety warnings in the PILs for these medicines did not clearly explain certain side effects – specifically suicidal behaviours, and sexual dysfunction that may continue after the treatment is stopped.

Over the past 18 months, the EWG has heard directly from families, patients, and mental health support organisations. The group considered the real-world experiences of those affected, together with the scientific literature, to understand how warnings could be made clearer and more easily understood by patients.

Based on the group’s recommendations, the CHM has advised that the wording in the PILs provided with antidepressant medications should be strengthened to provide greater clarity on the risk of suicidal behaviour. The revised text will be further developed through user testing to ensure it is as clear and effective as possible, and the MHRA is exploring a range of engagement options to take this advice forward.

The CHM has also recommended updates to the PILs for certain antidepressants to better reflect patient feedback and emerging evidence on the potential for sexual dysfunction that may continue after stopping treatment.

Several additional communication measures have been agreed, including:

the introduction of a patient card to be given to patients by their healthcare professional or included in the medicine pack and available digitally to further highlight the risk of suicidal behaviour;

an ancillary leaflet to support discussions between patients and healthcare professionals regarding the risk of suicidal behaviour developed with wider healthcare system partners

The MHRA is engaging with the National Institute for Health and Care Excellence (NICE), the British National Formulary (BNF), and the Royal Colleges of General Practice and Psychiatrists to improve consistency of safety messaging in a range of additional communications.

The MHRA recognises that many families and patients are waiting to see the final products that have been developed as a result of the review. While regulatory processes are ongoing there are limitations in the level of detail the MHRA is able to communicate. As soon as the regulatory position is finalised, the MHRA is committed to communicating on the final products as quickly as possible.

Patients should continue taking their medicines as prescribed and not stop or change treatment without first speaking to a doctor or mental health professional. Please also read the PIL which contains important information about your medicine. Anyone experiencing side effects should seek medical advice and report suspected side effects via the Yellow Card scheme (https://yellowcard.mhra.gov.uk/).

Notes to Editors:

Antidepressants, including selective serotonin reuptake inhibitors (SSRIs), are widely used for the treatment of depression and other mental health conditions. The MHRA rigorously monitors the safety of these medicines, including side effects and emerging evidence.

As well as having beneficial effects, antidepressants can cause side effects in some people, and in some cases these can be severe. Details of possible side effects are provided in the Patient Information Leaflets (PILs) accompanying these medicines.

All known side effects associated with individual antidepressants are outlined in the Summary of Product Characteristics (SmPC) for healthcare professionals and reflected in lay language in the PILs which can be found in the medicine packs.

If you’re having suicidal thoughts, help is available now. You can call NHS 111 (24 hours every day), Samaritans on 116 123, or text “SHOUT” to 85258. Find more information and support options on the NHS website (https://www.nhs.uk/mental-health/feelings-symptoms-behaviours/behaviours/help-for-suicidal-thoughts/).

The Commission on Human Medicines (CHM) (https://www.gov.uk/government/organisations/commission-on-human-medicines) is an independent statutory body, whose members are appointed directly by ministers. Members are not employees of the Agency and are appointed to advise government (Health Ministers), through the licensing authority (the Medicines and Healthcare products Regulatory Agency (MHRA)).

The Antidepressant Risk Minimisation Expert Working Group (https://www.gov.uk/government/organisations/commission-on-human-medicines/about/membership%22%20/l%20%22antidepressant-risk-minimisation-expert-working-group) was set up to advise the CHM on any recommendations for additional risk minimisation measures on the risk of suicidal behaviour associated with all antidepressants and sexual dysfunction which may continue on stopping treatment.

The MHRA is an executive agency of the Department of Health and Social Care.

The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and evidence -based assessments by multi-disciplinary teams to ensure that the benefits justify any risks.

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