Antidepressant leaflets to get boxed warning on suicidal thoughts
The aim is “not to discourage use”, says the MHRA’s Dr Alison Cave, with a new patient card also planned.
Patient information leaflets for antidepressants are to carry a new boxed warning on suicidal thoughts and behaviours, the Medicines and Healthcare products Regulatory Agency (MHRA) announced on 15 October.
The change follows a review started by the Commission on Human Medicines (CHM) after patients and families raised concerns about how two risks are explained in the leaflets: suicidal thoughts and behaviours, and sexual dysfunction that continues after treatment is stopped.
What patients will see
The boxed warning is meant to make the information easier to find, and to signpost where patients can get help. A new patient card is also planned, and the MHRA expects it to be included in or on the medicine box.
The agency’s Drug Safety Update says the card will first be available electronically. The hard copy is expected to be credit card sized and easy to carry.
The term “Post SSRI Sexual Dysfunction” (PSSD) is also being added to the leaflets of some antidepressants, to explain the risk of symptoms continuing after treatment is stopped. The update lists ten antidepressants associated with that risk: citalopram, escitalopram, duloxetine, fluvoxamine, fluoxetine, paroxetine, sertraline, venlafaxine, amitriptyline and nortriptyline.
A supporting safety leaflet is being developed. Due in 2027, it will describe the key risks and benefits, and will be given to patients at their first appointment discussing antidepressants as well as to people already taking them.
What the regulator says
Dr Alison Cave, the MHRA’s Chief Safety Officer, said antidepressants are effective medicines for depression and other conditions, and that “for the vast majority of individuals, the benefits outweigh the risks” when they are used appropriately under clinical supervision. “The aim is not to discourage use, but to improve the prominence and clarity of the existing warnings,” Cave said.
“It’s imperative that patients do not stop taking these medicines without first speaking to their healthcare professional,” Cave added.
The review’s expert working group met between May 2024 and July 2025. The MHRA then worked with the Patients Association, which brought together a patient focus group to refine the leaflets’ wording and format.
Help and reporting
The Drug Safety Update advises anyone with new or worsening suicidal thoughts, particularly when starting an antidepressant or changing the dose, to seek urgent medical attention. It says people can call NHS 111 or a local mental health crisis team. It lists Samaritans on 116 123, and says people can text “SHOUT” to 85258.
The update’s advice for patients says “these are not new risks for these medicines, but it is important to be aware of them”.
Anyone who suspects a side effect is encouraged to talk to a healthcare professional and report it through the Yellow Card scheme, the MHRA said.
