MHRA adds boxed warning and patient card to leaflets for antidepressants

The MHRA said on 15 October 2026 that new safety measures for antidepressants are now being put in place for every patient who takes them, covering how the risks of suicidal thoughts and behaviours and of sexual dysfunction that can persist after treatment are explained ¹. The changes follow a review by an Expert Working Group of the Commission on Human Medicines (CHM) of the warnings for 28 antidepressant medicines ².

What the regulator decided

Three new tools sit at the centre of the package. The patient information leaflet (PIL) gains a boxed warning on suicidal thoughts and behaviours that also tells patients where to get help ¹. A patient card repeating the key safety messages will exist in digital and printed form, with the printed version expected to be the size of a credit card; at first only the electronic card is available, and dispensers may hand it out as a stopgap ¹. A separate safety (ancillary) leaflet setting out benefits, risks and alternatives is being written with other health system partners and will reach patients in 2027 ¹.

The leaflets of antidepressants linked to sexual dysfunction that may last after stopping will also name the condition as "Post SSRI Sexual Dysfunction" (PSSD) ¹. The MHRA lists 10 medicines in this group: citalopram, escitalopram, duloxetine, fluvoxamine, fluoxetine, paroxetine, sertraline, venlafaxine, amitriptyline and nortriptyline ¹. The regulator stressed that these are "not new risks for these medicines" ¹.

Prescribers are asked to raise the suicide risk with patients when an antidepressant is started, when the dose changes, or at the next review, and to tell them to get urgent care if suicidal intent appears or worsens ¹. They are also asked to discuss the evidence on persistent sexual dysfunction, follow NICE guidance, monitor patients after starting treatment and report suspected reactions through the Yellow Card scheme ¹.

The decision took more than two years from the first meeting of the working group. The working group met from May 2024 to July 2025 and the CHM considered its recommendations in September 2025 ¹. Patients and bereaved families gave evidence directly, and the working group weighed their views against the literature published since 2019, the last time the regulatory position on these risks was reviewed at committee level ¹. The CHM then asked for the new wording to be user tested, and the MHRA refined it with a focus group of patients convened by the Patients Association ¹.

What it means for the market

For marketing authorisation holders of the affected products, the decision means revised PILs and new risk minimisation materials across a class of medicines that the MHRA describes as widely used ¹². The link to the electronic patient card will be supplied in a Direct Healthcare Professional Communication (DHPC) ¹.

The measures also reach well beyond the pack. The MHRA is coordinating work over the coming months on possible updates to NICE guidelines, the British National Formulary and NHS guidance, and with the Royal Colleges of General Practice, Psychiatrists and Pharmacy ¹. A Public Assessment Report setting out the data the working group considered has been published ¹. For medical affairs and pharmacovigilance teams, the case shows the UK regulator reopening the communication of known risks in response to patient concerns, and making user testing with patients part of how new wording is settled ¹².

What is not yet known is the timetable for changing PILs across all products, and how the patient card will be printed and distributed beyond the interim electronic version ¹.

Caveats

The measures change how existing risks are communicated rather than reporting new safety findings, and the MHRA tells patients not to stop treatment without first talking to a health professional ¹. The ancillary leaflet, which prescribers are meant to hand over at a new patient's first consultation or an existing patient's next one, will not be available until 2027 ¹.