Article · Health news

MHRA adds antidepressant safety safeguards

Health news Published · sources checked

On 15 October 2026 the MHRA announced new safeguards for antidepressant safety information after a review of 28 antidepressants, covering suicidal thoughts and behaviours and sexual dysfunction that continues after stopping.

Key points

  • The MHRA announced the measures on 15 October 2026 after a review by an expert working group of the Commission on Human Medicines.
  • The review looked at how two risks are communicated to patients for 28 antidepressant medicines.
  • The measures include a boxed warning in patient leaflets, a patient card and a new safety leaflet.

What was announced

The MHRA says an expert working group of the Commission on Human Medicines has finished a detailed review of how the potential risks of 28 antidepressant medicines are communicated to patients. The review began after concerns from patients and families about the information in patient information leaflets.

The two risks are suicidal thoughts and behaviours, and sexual dysfunction that continues after treatment is stopped.

What changes

The MHRA lists a new boxed warning in the leaflets, to highlight information on suicidal thoughts and behaviours and point to where help can be found. A new patient card, in digital or paper form, reinforces key safety messages. A new safety leaflet is being developed with other health system partners and can be given out by healthcare professionals. The MHRA has also published a public assessment report on the review.

If you or someone else is in immediate danger, call 999. For urgent mental health help, NHS 111 offers a mental health option, and Samaritans are free to call on 116 123 at any time. The site's SSRI, sertraline and citalopram pages cover this group of medicines.

More guides and news

Educational content. This article summarises public guidance and announcements in plain English for education. It is not medical advice and it cannot say what is right for you: speak to a clinician about your own health, call NHS 111 if you are unsure what to do and 999 in an emergency.