The Medicines and Healthcare products Regulatory Agency (MHRA) is introducing new measures to strengthen antidepressant safety information for patients, carers and healthcare professionals. The measures, announced on 15 October 2026, include a new boxed warning in patient information leaflets, a patient card and a separate safety leaflet due in 2027.
Review prompted by patient and family concerns
The changes follow an extensive review initiated by the Commission on Human Medicines (CHM). Patients and families had raised concerns about how two areas are communicated in patient information leaflets: suicidal thoughts and behaviours, and sexual dysfunction that continues after treatment is stopped.
The MHRA said it engaged directly with patients and families during the review and considered the latest available evidence and expert clinical advice. The agency regulates all medicines and medical devices in the UK and is an executive agency of the Department of Health and Social Care.
Changes to antidepressant safety information in leaflets
Patient information leaflets for antidepressants will be updated to include a new boxed warning that signposts readers to information on suicidal thoughts and behaviours, with the aim of making it easier to find. The MHRA said the expectation is that a new patient card will also be included in or on the medicine box to reinforce key safety messages and help patients and carers understand how and when to get further support.
Leaflets for certain antidepressants will also be updated to include the term Post SSRI Sexual Dysfunction (PSSD), to explain the risk of symptoms continuing after treatment is stopped. According to the regulator, this update is intended to better reflect patient experiences and existing safety information.
Safety leaflet for new and existing patients
The MHRA is developing a supporting safety, or ancillary, leaflet with the wider healthcare system. It will be given to patients at their first appointment discussing antidepressants and will set out the key risks and benefits to support informed decisions about treatment.
The leaflet will also be given to patients who are already receiving antidepressants. It will be available in 2027.
Regulator says aim is clarity, not discouraging use
Dr Alison Cave, MHRA Chief Safety Officer, said: “Patients need clear and accessible information about the benefits and risks of medicines so they can make informed decisions. We are incredibly grateful for the valuable contributions of patients, families, clinicians and experts to this review.”
She added: “These measures will help ensure patients, carers and healthcare professionals can have more informed conversations about the benefits and risks associated with antidepressant medicines, and better support people throughout their treatment.”
Dr Cave also said: “Antidepressants are effective medicines for the treatment of depression and other conditions. When used appropriately and under clinical supervision, for the vast majority of individuals, the benefits outweigh the risks. The aim is not to discourage use, but to improve the prominence and clarity of the existing warnings.” She stressed: “It’s imperative that patients do not stop taking these medicines without first speaking to their healthcare professional.”
NICE to consider implications for its guidance
The National Institute for Health and Care Excellence (NICE) took part in the review, with its staff joining the expert working group. Chris Bird, programme manager for patient safety at NICE, said: “This review will ensure patients and healthcare professionals have the most up to date information to help them make crucial decisions on treatment and support.”
He added: “We are grateful to have collaborated with the MHRA on the review, with NICE colleagues joining its expert working group. As with all new safety advice issued from the MHRA, we will consider the implications of this advice on published NICE guidance and review our recommendations if required.”
The MHRA said it will continue working with partners on more consistent communication of antidepressant risks, including updates to prescribing resources, clinical guidance and patient information materials. A detailed Public Assessment Report has been published alongside the updated antidepressant safety information. The agency encourages anyone who suspects a side effect to speak to their healthcare professional and report it through the Yellow Card scheme.
Frequently asked questions
What changes is the MHRA making to antidepressant patient information?
Patient information leaflets will include a new boxed warning signposting to information on suicidal thoughts and behaviours, and a patient card is expected to be included in or on the medicine box. Leaflets for certain antidepressants will also include the term Post SSRI Sexual Dysfunction (PSSD).
What is Post SSRI Sexual Dysfunction (PSSD)?
The MHRA uses the term to describe the risk of sexual dysfunction symptoms continuing after antidepressant treatment is stopped. It will appear in patient information leaflets for certain antidepressants.
When will the new antidepressant safety leaflet be available?
The supporting safety (ancillary) leaflet will be available in 2027. It will be given to patients at their first appointment discussing antidepressants and to those already receiving them.
Should patients stop taking antidepressants after this review?
No. The MHRA said the aim is not to discourage use but to make existing warnings clearer, and that patients should not stop taking these medicines without first speaking to their healthcare professional.
How can side effects from antidepressants be reported in the UK?
The MHRA encourages anyone who suspects a side effect to talk to their healthcare professional and report it through the Yellow Card scheme.
