The Medicines and Healthcare products Regulatory Agency has announced immediate changes to how risks associated with antidepressant medicines are communicated to patients, carers and healthcare professionals across the United Kingdom. The move follows a major, multi year review carried out by a Commission on Human Medicines expert working group, and aims to make critical safety information easier to find and discuss.
What the MHRA decided
Published by the MHRA today, the regulatory actions require patient information leaflets that accompany antidepressant medicines to include a new boxed warning signposting readers to information about suicidal thoughts and behaviours. For antidepressants linked to persistent sexual problems after treatment, the patient information leaflets will also be updated to include the phrase Post SSRI Sexual Dysfunction, sometimes abbreviated as PSSD, so that patient experiences are reflected in the formal safety materials.
In addition, the MHRA will introduce a patient safety card, initially in electronic form and later as a hard copy card, to be given to patients at dispensing or made available by prescribers. A supporting safety leaflet, described as an ancillary leaflet, will be developed with system partners and made available from 2027. The ancillary leaflet is intended to be supplied at a patient’s first consultation about antidepressants, or at the next consultation for people already receiving these medicines.
Why the change was made
The Commission on Human Medicines convened an expert working group to examine whether existing patient information leaflets clearly communicated two concerns that patients and families have repeatedly raised: the potential for suicidal thoughts and behaviours, particularly early in treatment or after dose changes, and the possibility of sexual dysfunction that may continue after stopping some antidepressants.
The working group met between May 2024 and July 2025 and its recommendations were considered by the CHM in September 2025. The review included direct engagement with patients and families and a review of the scientific literature, creating a combined evidence base of clinical and lived experience that informed the updated guidance.
What the changes require from clinicians and pharmacists
The MHRA Drug Safety Update accompanying the announcement sets out practical expectations for healthcare professionals. Clinicians and prescribers are asked to discuss the risk of suicidal thoughts and behaviours when initiating or changing the dose of an antidepressant, and to advise patients to seek urgent medical attention, including NHS 111 or local crisis services, if they experience new or worsening suicidal intent.
Prescribers and dispensers are also instructed to raise awareness of sexual side effects and the potential for symptoms to persist after stopping treatment, and to signpost patients to the new patient card and forthcoming ancillary leaflet. Pharmacists are advised to ensure they and their teams are familiar with the updated advice and consider refresher suicide awareness training where appropriate, for example the Zero Suicide Alliance training referenced in the guidance.
Which medicines are affected
The MHRA names a wide range of commonly prescribed antidepressant medicines in the Drug Safety Update. These include selective serotonin reuptake inhibitors and other drugs frequently used in primary and secondary care. The announcement notes that the updated wording and materials do not introduce previously unknown risks, but give greater prominence and clarity to existing safety information so patients can make more informed choices.
System level work and implementation timeline
The MHRA said the patient card will initially be available in digital form and that hard copy cards are expected to follow. The ancillary safety leaflet requires cross‑system collaboration and is planned for release in 2027. To ensure consistent messaging across the NHS and professional bodies, the MHRA will coordinate updates to prescribing resources including the British National Formulary and will work with NICE, NHS England and the Royal Colleges so guidance and clinical pathways can be reviewed and, where necessary, updated.
The regulator also published a Public Assessment Report setting out the evidence reviewed by the expert working group, and reiterated that suspected side effects should be reported through the MHRA Yellow Card scheme. The agency emphasised that the aim of the measures is not to discourage appropriate use of antidepressants, but to support safer, better informed care.
Why this matters to patients and services
Antidepressants remain a mainstay of treatment for depression and many other conditions when used under clinical supervision. However, both clinicians and patient groups have campaigned for clearer, more accessible safety information that reflects patient experience. The boxed warning, patient card and ancillary leaflet are designed so patients and carers can spot warning signs early, know where to get help and have a clearer basis for discussing treatment choices with clinicians.
For NHS services and community pharmacies, the changes will require updating dispensing procedures, patient counselling practices and educational materials. For prescribers the guidance underscores the need for active follow up after initiation and dose changes.
Patients already taking antidepressants are advised not to stop medication without first speaking to a healthcare professional. Anyone concerned about new or worsening suicidal thoughts should seek urgent help from NHS 111, their local crisis team, Samaritans on 116 123, or text SHOUT to 85258.
The MHRA press release and the Drug Safety Update were published on 15 October 2026 and will be the basis for implementation work across the healthcare system in the coming months.
