MHRA announces boxed warning and patient card for antidepressants in the UK

The Medicines and Healthcare products Regulatory Agency (MHRA) said on 15 October 2026 that it is changing the safety information supplied with antidepressants in the UK, after a review of how two risks are communicated to patients: suicidal thoughts and behaviours, and sexual dysfunction that continues after treatment stops. The review was started by the Commission on Human Medicines (CHM) after patients and families raised concerns about patient information leaflets, the MHRA said.

The agency said the aim is to make existing warnings more prominent and clearer, not to discourage use of the medicines. A Public Assessment Report published alongside the announcement says 28 antidepressants authorised in the UK were in scope, covering selective serotonin reuptake inhibitors (SSRIs), serotonin and noradrenaline reuptake inhibitors (SNRIs), tricyclics, monoamine oxidase inhibitors and other classes.

What changes for marketing authorisation holders

According to the assessment report, patient information leaflets will carry a new boxed headline, placed above any headlines or existing boxed warnings, that signposts patients and carers to the section 2 information on thoughts of self-harm and suicidal behaviour. The report says the expert working group did not support introducing a black box warning of the kind that has a specific legal basis under the US Food and Drug Administration framework. Section 2 wording on suicidal thoughts and on sexual dysfunction will be revised, and any section 1 wording that describes antidepressants as correcting certain chemical imbalances is replaced with revised text on how the medicines work, the report says.

The MHRA said it expects a new patient card to be included in or on the medicine box, and the assessment report says the card will be available in print and electronically. Leaflets for certain antidepressants will use the term Post SSRI Sexual Dysfunction (PSSD), the MHRA said. The assessment report limits the term to antidepressants for which there is sufficient evidence of an association. Its proposed leaflet wording covers citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine and venlafaxine, with amitriptyline and nortriptyline added. The report also records advice from the CHM that the term PSSD should be added to section 4.4 of the summary of product characteristics for drugs without existing warnings.

Timelines and the supply chain

The assessment report says updated leaflets will be introduced through the standard regulatory update process and will start to appear in medicine boxes within the next six months, with electronic leaflets available sooner. Printed patient cards are expected through routine packaging updates, and the report says the MHRA encourages dispensing practices and pharmacies, where feasible, to provide patients with a printed copy of the card on request. A written parliamentary answer from health minister James Frith, published on 12 October 2026, said paper copies within packs would follow within three to six months and that, as an interim measure, the MHRA was working with manufacturers’ trade associations to look at earlier access to hard copies for patients via pharmacies, The Pharmaceutical Journal reported.

A separate supporting leaflet, which the MHRA said it is developing with the wider healthcare system, will be available in 2027, according to the agency. The expert working group recommended that this leaflet be developed jointly by the MHRA, the Royal College of Psychiatrists and the Royal College of General Practitioners rather than by marketing authorisation holders, the assessment report says. Chris Bird, programme manager for patient safety at NICE, said NICE will consider the implications for its published guidance and review its recommendations if required, according to the MHRA announcement. The assessment report does not state which variation procedure manufacturers must use.

The aim is not to discourage use, but to improve the prominence and clarity of the existing warnings.

Dr Alison Cave, MHRA Chief Safety Officer

Our reading

• The Healthcare Daily’s reading: for marketing authorisation holders this is largely an artwork, leaflet and packaging exercise, with updated paper leaflets due to start appearing in packs within about six months on the MHRA’s timetable.
• A card expected in or on each pack is an added packaging component, not only a text change. Packaging suppliers and wholesalers should plan for a period in which old and new packs circulate together.
• The MHRA’s work with trade associations points to community pharmacies acting as the interim channel for paper copies while packs change over. None of the documents reviewed mentions funding or a service specification for that role.