An Expert Working Group (EWG) of the Commission on Human Medicines (CHM), advising the Medicines and Healthcare Products Regulatory Agency (MHRA), has completed an in‑depth review of how the risks of 28 antidepressant medicines are described in Patient Information Leaflets (PILs). The review focused on whether current leaflets clearly explain suicidal behaviors and sexual dysfunction that may persist after stopping treatment, following concerns raised directly by patients and families.
Over 18 months, the EWG listened to the experiences of patients, families, and mental health support organizations, and examined scientific evidence to identify how risk messages could be clearer and easier to understand. As a result, the CHM has recommended that the wording in antidepressant PILs is strengthened to give more explicit information on the risk of suicidal behavior. The revised text will be refined and user‑tested to ensure that it is clear, accessible, and genuinely helpful for patients in real‑world settings.
The CHM has also advised updating the PILs of certain antidepressants to better reflect patient feedback and emerging evidence on sexual dysfunction that may continue after treatment is stopped. To support safer use in practice, several additional communication measures are planned, including: a patient card (paper or digital) to highlight the risk of suicidal behavior, and an ancillary leaflet designed to support conversations between patients and healthcare professionals about this risk.
The MHRA is working with National Institute for Health and Care Excellence (NICE), the British National Formulary (BNF), and the Royal Colleges of General Practitioners and Psychiatrists to improve consistency of safety messaging across guidelines and professional resources. While regulatory work is ongoing, the MHRA acknowledges that many patients and families are waiting to see the final materials, and has committed to sharing them as soon as the regulatory position is finalized.
Patients are advised not to stop or change antidepressant treatment without speaking to a doctor or mental health professional. Reading the PIL remains important, and anyone experiencing side effects should seek medical advice and report suspected side effects through the Yellow Card scheme.
Learn more: Patient and family experiences inform antidepressant safety information review
