Antidepressant medicines in the UK will carry clearer safety information under changes announced by the Medicines and Healthcare products Regulatory Agency, according to the MHRA. The move follows a review ordered by the Commission on Human Medicines after patients and their families said leaflets did not explain certain risks well enough.
The review looked at two areas in particular: suicidal thoughts and behaviours, and sexual dysfunction that persists after someone stops taking the medicine. The regulator said it had heard directly from patients and families and had weighed the latest evidence alongside clinical advice.
Key points
- Boxed warning — leaflets will carry a prominent box pointing to information on suicidal thoughts and behaviours.
- Patient card — a card is expected to be included in or on the medicine box, setting out key safety messages and where to get support.
- New term — leaflets for some antidepressants will name Post SSRI Sexual Dysfunction (PSSD) to explain symptoms that continue after treatment ends.
- Extra leaflet — a supporting safety leaflet, developed with the wider healthcare system, is due in 2027.
Dr Alison Cave, the MHRA's Chief Safety Officer, said patients need information that is clear and easy to get hold of so they can make informed choices. She said the agency was grateful to the patients, families, clinicians and experts who took part, and that the measures should help patients, carers and health professionals have better conversations about benefits and risks.
She also stressed that antidepressants work for depression and other conditions, and that for most people the benefits outweigh the risks when the medicines are used properly and monitored by a clinician. The aim, she said, is to make existing warnings more prominent and clearer rather than to put people off treatment, and patients should speak to their healthcare professional before stopping.
Chris Bird, programme manager for patient safety at NICE, said the review would give patients and health professionals up-to-date information for decisions about treatment and support. He said NICE had worked with the MHRA on the review, with its colleagues joining the expert working group, and that the body would look at what the new safety advice means for its published guidance and review recommendations if needed.
The MHRA said it will keep working with partners across the health system on more consistent communication of antidepressant risks, including updates to prescribing resources, clinical guidance and patient information. A detailed Public Assessment Report has been published alongside the updated safety information, and the agency continues to monitor these medicines, with side effects reportable through the Yellow Card scheme.
What it means in practice
For anyone in the UK taking an antidepressant, or caring for someone who does, the paperwork that comes with the medicine is set to change. The warnings already exist; what is changing is how easy they are to find and how plainly they are worded. Nothing here changes who can be prescribed these medicines or how they are dispensed.
- Check the box — when a new pack arrives, look for the boxed warning and the patient card, and keep the card somewhere you can find it.
- Don't stop suddenly — talk to your GP, pharmacist or other healthcare professional before changing or ending treatment.
- Report problems — if you think you have had a side effect, tell a healthcare professional and report it to the Yellow Card scheme.
