96 million prescriptions a year, and a new warning box on the leaflet
What happened
On 15 October 2026 the UK's medicines regulator announced changes to the safety information that comes with antidepressants. The Medicines and Healthcare products Regulatory Agency (MHRA) published them in its Drug Safety Update and in a press release the same day. Nothing about the medicines themselves has changed. What is changing is how two risks are explained to patients. There are four measures. A new boxed warning in the patient information leaflet – the folded paper inside the box. It will highlight information about suicidal thoughts and behaviours, and point you to where you can get help. A new patient card, reinforcing the key safety messages and explaining how to get support. The MHRA expects the paper version to be credit-card sized, so it is easy to carry. It will be electronic first, and pharmacy teams may hand it out in the meantime. The term “post SSRI sexual dysfunction”, shortened to PSSD, added to the leaflets of some antidepressants. It describes sexual side effects that may carry on after someone has stopped the medicine. The medicines affected are citalopram, escitalopram, duloxetine, fluvoxamine, fluoxetine, paroxetine, sertraline, venlafaxine, amitriptyline and nortriptyline. And a separate safety leaflet, written with the rest of the healthcare system, covering benefits, risks and alternatives. The MHRA says it will be available in 2027 and given to new patients at their first appointment about antidepressants, and to existing patients at their next one. This is the end of a long piece of work. An Expert Working Group met from May 2024 to July 2025, set up because patients and families said the leaflets did not explain these risks well enough. It read research published since 2019 and listened to families and individual patients. The Commission on Human Medicines considered its recommendations in September 2025 and asked for the stronger wording to be tested with patients first. The MHRA then worked with the Patients Association and a patient focus group on the final wording. Dr Alison Cave, the MHRA's Chief Safety Officer, said patients “need clear and accessible information” about the benefits and risks of their medicines, so they can make decisions with confidence.
Why this matters
This affects a very large number of people. NHS Business Services Authority figures published on 23 July 2026 show 96 million antidepressant items were prescribed in England in 2025/26, to an estimated 9.1 million identified patients. That was 3.1% more items than the year before. Women made up about 65% of those patients: 5.9 million women and 3.2 million men. The leaflet matters more than it might seem. For many people it is the only written information they get about a medicine they will take for months or years. A ten-minute appointment is not long, and people often remember the dose and little else. The MHRA's own reason for making these changes is that patients and families told it the leaflet was not doing its job. There is a second reason this matters, and it is worth saying plainly. The MHRA is not telling anyone to stop. It says that when these medicines are used properly and with clinical supervision, the benefits outweigh the risks for most people. The point is to make existing warnings clearer, not to put people off treatment that is helping them. That distinction is easy to lose in a headline. If a news alert about suicide warnings on antidepressants reaches someone already anxious about their medicine, the risk is they stop on their own. Stopping suddenly can cause withdrawal symptoms, and can let the original illness come back. The regulator's advice is the opposite: keep taking it, and talk to someone.
What the evidence actually says
It helps to separate what is new from what is not. The risk of suicidal thoughts and behaviours with antidepressants is not a new finding. It has been on UK product information for years. What the review concluded is that the warning was not prominent enough, and did not tell people where to turn. The MHRA's advice to prescribers is to discuss this risk when starting an antidepressant, when changing the dose, or at the next review. The risk is described as higher early in treatment and after dose changes. Sexual side effects are also already known. Reduced interest in sex and difficulty reaching orgasm are listed side effects of many antidepressants. What is new is the leaflet naming the possibility that these symptoms continue after the medicine is stopped, using the term patients themselves use. Here it is worth being careful about what has and has not been established. The MHRA's wording is that there is evidence linking some antidepressants to sexual dysfunction that “may continue” after stopping. The regulator has not published a figure for how common that is, and the review does not claim one. Adding the term to the leaflet is a decision about honest labelling: the symptom is recognised, it has a name, and patients should be told it is possible. It is not a statement that it is common. A Public Assessment Report setting out the data the review drew on has been published for anyone who wants the detail. Alongside the leaflets, the MHRA says prescribing resources, clinical guidance and patient materials are being updated across the healthcare system over the coming months – including NICE guidance, the British National Formulary, work with the royal colleges and NHS guidance. Chris Bird, programme manager for patient safety at NICE, said the aim is to give patients and clinicians “the most up to date information”, and that NICE will review its recommendations if needed.
Qurexa perspective
We deliver prescriptions to people's doors across Lincolnshire, and a good share of what we carry is medicine someone takes every day for their mental health. Two practical things stand out. The first is the leaflet. When a medicine arrives at your door rather than being handed over a counter, there is no one to say “have a read of this”, and it is easy for the leaflet to go in the recycling with the bag. This is a month where it is genuinely worth keeping – and the new patient card is designed to live in a purse or wallet, not a bin. The second is timing. Updated leaflets and cards go online first, with printed copies following in packs, so for a while the box in your hand may have older wording than the version online. To read the current leaflet, look it up on the MHRA's own products website. And a leaflet is never a reason to stop. If something you read worries you, your community pharmacist can talk it through, usually the same day and without an appointment.
Practical advice
Do not stop taking your antidepressant because of a headline. The MHRA is explicit about this. Speak to your GP, pharmacist or mental health team first. Coming off an antidepressant is usually done slowly and with support. Read the new leaflet when it reaches you, and keep the patient card. If it is offered electronically, save it somewhere you will find it again. Know what to do if suicidal thoughts appear or get worse. The MHRA's advice is to seek urgent medical attention. You can call NHS 111, contact your local mental health crisis team, call Samaritans free on 116 123, or text SHOUT to 85258. If someone is in immediate danger, call 999. Be especially alert in the first few weeks of a new antidepressant and after any dose change. Those are the points the regulator singles out. If you have sexual side effects, raise them. It is an awkward conversation and plenty of people never have it. It is now a named, recognised side effect in the leaflet, which makes it a legitimate thing to bring to an appointment, and it may affect which medicine suits you best. Ask for a review if you have been on the same antidepressant a long time without one. The MHRA's advice to prescribers includes discussing these risks at the next review, so there is a clear reason to book. Report side effects through the Yellow Card scheme at yellowcard.mhra.gov.uk. Reviews like this one are built partly from reports sent in by ordinary patients – PSSD is being named at all because patients and families kept raising it.
What to know
On 15 October 2026 the MHRA announced four changes to antidepressant safety information: a boxed warning in the patient leaflet about suicidal thoughts and behaviours, a credit-card-sized patient card, the term PSSD added to leaflets for ten named antidepressants, and a fuller safety leaflet due in 2027. These are not new risks. They are existing risks explained more clearly, after a review prompted by patients and families who said the old leaflets were not good enough. The MHRA says benefits still outweigh risks for most people when these medicines are used with clinical supervision, and that nobody should stop without speaking to a healthcare professional first. If you need help now: NHS 111, your local crisis team, Samaritans on 116 123, or text SHOUT to 85258. Call 999 in an emergency. Sources: MHRA, “Antidepressants: new safety measures for all patients to improve communication of the risk of suicidal thoughts and behaviours and persistent sexual dysfunction”, Drug Safety Update, 15 October 2026, https://www.gov.uk/drug-safety-update/antidepressants-new-safety-measures-for-all-patients-to-improve-communication-of-the-risk-of-suicidal-thoughts-and-behaviours-and-persistent-sexual-dysfunction; MHRA, “MHRA introduces new safeguards to strengthen antidepressant safety information following major review”, 15 October 2026, https://www.gov.uk/government/news/mhra-introduces-new-safeguards-to-strengthen-antidepressant-safety-information-following-major-review; NHS Business Services Authority, “96 million antidepressant items prescribed to 9.1 million patients in 2025/26, new NHSBSA data shows”, 23 July 2026, https://media.nhsbsa.nhs.uk/press-releases/3d8fbc38-d962-405d-838f-3fd6c383a6a0/96-million-antidepressant-items-prescribed-to-9-1-million-patients-in-2025-26-new-nhsbsa-data-shows; Chemist+Druggist, “MHRA updates antidepressant info to ‘strengthen’ safety warnings”, 15 October 2026, https://www.chemistanddruggist.co.uk/news/regulation/mhra-updates-antidepressant-info-to-strengthen-safety-warnings-JNZJ2LHONVBMRFRFSVOZXNBS2A/ This article is for general information and does not replace advice from a doctor, pharmacist or other qualified healthcare professional. Do not start, stop or change a prescribed medicine on the basis of a news article.
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