MHRA Introduces new safeguards to improve antidepressant safety information
by Harriet Belderbos · Open Access GovernmentThe Medicines and Healthcare products Regulatory Agency (MHRA) is introducing new measures to improve how antidepressant medicine risks are explained to patients, carers, and healthcare professionals
Announced on October 15, 2026, the changes follow an extensive review led by the Commission on Human Medicines (CHM), which considered concerns raised by patients and families about the clarity of existing safety information.
The review focused on two key areas: suicidal thoughts and behaviours, and sexual dysfunction that may continue after antidepressant treatment has stopped. The new measures aim to make important warnings easier to find and help patients make informed treatment decisions.
Clearer warning for patients
A new boxed warning will direct patients to information about suicidal thoughts and behaviours, helping them identify relevant advice more easily. A patient safety card is also expected to be included in or attached to medicine packaging, reinforcing key warnings and explaining when and how to seek further support.
The MHRA hopes these changes will encourage better communication between patients, carers and healthcare professionals throughout treatment.
Recognising the sexual side effects
The review also examined reports of sexual dysfunction continuing after antidepressant treatment has ended.
For certain antidepressant medicines, patient information leaflets will be updated to include the term Post SSRI Sexual Dysfunction (PSSD). This will help explain the possibility of persistent symptoms after stopping treatment and ensure that patient experiences are better reflected in medicine safety information.
The updates are intended to improve awareness of this potential risk and support more open discussions between patients and healthcare professionals.
New safety leaflet planned for 2027
The MHRA is working with organisations across the healthcare system to develop an additional patient safety leaflet covering the main benefits and risks of antidepressant medicines.
The leaflet will be provided to patients at their first appointment to discuss antidepressant treatment. It will also be available to people already taking these medicines, with publication planned for 2027.
The review involved patients, families, clinicians and independent experts, helping ensure that the updated information reflects both clinical evidence and the experiences of those affected.
Supporting informed treatment decisions
The MHRA has emphasised that antidepressants remain effective treatments for depression and other conditions. For most people, when prescribed appropriately and used under clinical supervision, the benefits outweigh the risks.
The new safeguards are designed to improve the communication of existing risks rather than discourage people from seeking treatment.
Patients are advised not to stop taking antidepressants without first speaking to their healthcare professional, as changes to treatment should be discussed with an appropriate clinician.
The MHRA will continue working with healthcare partners, including the National Institute for Health and Care Excellence (NICE), to improve prescribing resources, clinical guidance and patient information.
The MHRA has also published a detailed Public Assessment Report alongside the updated safety information, providing further information about the review and its recommendations.