The MHRA will update safety information for 28 antidepressants, strengthening warnings on suicidal behaviour and persistent sexual dysfunction after treatment.
Written By: Neha Vishwakarma, PharmD
Reviewed by: Pharmacally Editorial Team
The UK Medicines and Healthcare products Regulatory Agency (MHRA) will strengthen patient information for 28 antidepressants to improve communication of the risks of suicidal thoughts and behaviours and persistent sexual dysfunction after treatment stops. The measures include more prominent warnings in patient information leaflets (PILs), a portable patient safety card and a new supporting leaflet expected to become available in 2027.
Patient Information Leaflets to Highlight Suicide-Related Risks
The regulatory changes follow a review initiated by the Commission on Human Medicines (CHM) after patients and families raised concerns that existing warnings were difficult to find or understand. The review incorporated patient experiences, clinical advice and available scientific evidence covering antidepressants authorised in the UK.
Under the updated requirements, patient information leaflets will include a boxed warning directing readers to the relevant section on suicidal thoughts and behaviours. The revised information will emphasise when patients should seek help, including if their condition worsens after starting treatment. The MHRA also expects a portable patient card, included on or inside medicine packaging and available digitally, to reinforce key safety messages and explain where to obtain support.
The warnings will apply across age groups, although the review recognised that clinical trial data indicate a higher risk of suicidal thoughts and behaviours among young adults aged 18 to 25 years. The measures are intended to improve awareness and monitoring rather than discourage appropriate treatment.
Persistent Sexual Dysfunction to Be Explicitly Identified
The review also addresses sexual dysfunction that continues after antidepressant treatment ends. Updated leaflets for selected medicines will introduce the term post-SSRI sexual dysfunction (PSSD), reflecting reports of persistent symptoms and concerns that existing information does not adequately communicate their potential impact.
Reported symptoms include reduced libido, genital numbness, impaired orgasm and erectile dysfunction. Some patients have also described non-sexual symptoms. Although the term refers specifically to selective serotonin reuptake inhibitors (SSRIs), persistent symptoms have been reported following other antidepressants as well.
The evidence review identified substantial uncertainty about the frequency and natural history of PSSD. A study examining erectile dysfunction in male patients found that 4 of 866 patients (0.46%) had evidence of symptoms persisting for at least one month after stopping serotonergic antidepressants, based on prescriptions for phosphodiesterase-5 inhibitors. However, its definition, limited symptom coverage and study population prevent this estimate from establishing the overall incidence of PSSD.
Survey-based studies have also reported persistent symptoms, but their findings cannot reliably establish population-level risk. The MHRA therefore considers further research necessary to clarify how frequently the condition occurs and which factors may influence its development.
Review Challenges Oversimplified Explanations of Antidepressants
The updated safety communications will also remove references to antidepressants correcting a “chemical imbalance”. The revised explanation will reflect current scientific understanding: although these medicines affect neurotransmitters such as serotonin and noradrenaline, their therapeutic effects likely involve multiple biological and psychological mechanisms that are not yet fully understood.
The MHRA is coordinating with the National Institute for Health and Care Excellence (NICE), the British National Formulary and relevant professional bodies to improve consistency across prescribing guidance and patient information. The British National Formulary has removed the phrase “where necessary” from its advice on monitoring patients for suicidal thoughts and behaviours, reinforcing monitoring as a standard consideration for people receiving antidepressants.
Further Research and Implementation
The MHRA is developing a supporting safety leaflet with healthcare system partners. It will provide more detailed information about treatment benefits, risks and available support, and will be offered to patients starting antidepressants as well as those already receiving treatment. The leaflet is expected to be available in 2027.
The regulator also plans observational research using anonymised primary care data to investigate suicidal behaviour and persistent sexual dysfunction associated with antidepressant use. These studies could help clarify risk patterns and inform future safety measures.
MHRA Chief Safety Officer Dr Alison Cave emphasised that antidepressants remain effective treatments for depression and other conditions, with benefits outweighing risks for most patients when medicines are used appropriately under clinical supervision. Patients should not stop treatment without first consulting their healthcare professional.
The updated communications represent a regulatory effort to make safety information more accessible while preserving informed treatment decisions. The MHRA will continue monitoring adverse effects and encourages patients and healthcare professionals to report suspected side effects through the Yellow Card scheme.
Reference
Antidepressants – Updated safety communications on the risk of suicidal thoughts and behaviours and sexual dysfunction where symptoms continue after stopping treatment, Public Assessment Report, MHRA, 15 October 2026
MHRA introduces new safeguards to strengthen antidepressant safety information following major review, MHRA, 15 October 2026
About the Writer
Neha Vishwakarma (LinkedIn) is a Pharm.D professional with experience in clinical pharmacy, pharmacovigilance, and clinical research. She has hands-on experience in ADR assessment, ICSR processing, medication safety, and clinical data evaluation. Her research background in surgical site infections and antibiotic use supports her focus on evidence-based healthcare writing.