Antidepressants in the UK are to carry prominent new “boxed warnings” and patient safety cards. These will highlight the risks of suicidal thoughts, withdrawal effects, and persistent sexual dysfunction, the medicines regulator has confirmed.
The announcement by the Medicines and Healthcare Products Regulatory Agency (MHRA) follows an examination by the Commission on Human Medicines, prompted by concerns from patient groups and four “Prevention of Future Death” reports issued by coroners since 2020.
Among those was a high-profile report issued following the 2024 death of Thomas Kingston, husband of Lady Gabriella Kingston. An inquest at Gloucestershire Coroner’s Court heard that Mr Kingston, 45, died by suicide after being prescribed sertraline and later citalopram — both selective serotonin reuptake inhibitors (SSRIs) — alongside zopiclone, a sleeping tablet, for work-related stress and insomnia.
MORE ON HEALTH
Senior Coroner Katy Skerrett raised formal concerns over whether the risks associated with SSRIs, such as citalopram, sertraline, and fluoxetine, are adequately communicated to patients. Although Mr Kingston had not expressed suicidal ideation prior to his death, toxicology reports revealed he had recently stopped taking his medication, reports Neil Shaw for Yorkshire Live.
Mr Kingston’s parents, Martin and Jill Kingston, have pressed for reforms in how patients receive SSRI prescriptions. They argue that both the patient and those around them require clearer information about the medication’s potential adverse effects, including the consequences of discontinuing treatment.
WORK STRESS: Lady Gabriella Windsor and Thomas Kingston (Image: Getty)
Under the new MHRA measures, patient information leaflets will feature “boxed warnings” on suicidal thoughts and behaviours, clearer guidance on Post-SSRI Sexual Dysfunction (PSSD), and standalone safety cards inside medication packaging. Updated digital advice and clinical guidelines for healthcare workers will launch online this month, with physical cards appearing in pharmacy packs over the next three to six months. An additional consultation leaflet is scheduled for release in 2027.
Dr Alison Cave, Chief Safety Officer at the MHRA, emphasised that antidepressants remain safe and effective for the vast majority of patients when taken under clinical supervision.
“These measures will help ensure patients, carers and healthcare professionals can have more informed conversations about the benefits and risks associated with antidepressant medicines, and better support people throughout their treatment,” Dr Cave said. “It is imperative that patients do not stop taking these medicines without first speaking to their healthcare professional.”
READ NEXT