The Medicines and Healthcare products Regulatory Agency (MHRA) is to introducing a requirement for enhanced information on suicidal thoughts and sexual dysfunction for the use of antidepressants .
This follows a review initiated by the Commission on Human Medicines (CHM) in response to concerns raised by both patients and families, which considered latest available evidence and expert clinical advice, and engaged with patients and families.
A Drug Safety Update said that safety measures are being implemented to improve how the risks of suicidal thoughts and behaviours and persistent sexual dysfunction are communicated to patients taking antidepressant medications.
A leaflet will be produced to be given to patients receiving antidepressant medication, including those receiving the medication for the first time.
Patient information leaflets for antidepressants will be updated to include signposting to information on suicidal thoughts and behaviours, to reinforce key safety messaging and to help patients and carers understand how and when to get further support.
Patient information leaflets for some antidepressants will be updated to include the term ‘Post SSRI Sexual Dysfunction’ (PSSD), to explain the risk of symptoms continuing after stopping treatment.
An MHRA statement said: "Patient information leaflets for antidepressants will be updated, including a new boxed warning signposting to information on suicidal thoughts and behaviours, making information easier to find. The expectation is that a new patient card will be included in or on the medicine box to reinforce key safety messaging and help patients and carers understand how and when to get further support."
A supporting safety (ancillary) leaflet will be developed, to be given to patients at their first appointment discussing antidepressants. This will describe the key risks and benefits to support informed decision making about their treatment.
This leaflet is to also be given to patients who are already receiving antidepressants, and will be available in 2027.
Dr Alison Cave, MHRA Chief Safety Officer, said: “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.”
The aim is not to discourage use, but to improve the prominence and clarity of the existing warnings, she added.
In May, MHRA strengthened its warnings about potential psychiatric and sexual dysfunction linked to finasteride, and to provide precautionary advice on dutasteride.
MHRA published separate sets of advice for healthcare professionals and patients.
Advice for healthcare professionals
- Discuss suicidal ideation: Talk to patients about the risk of suicidal thoughts and behaviours when initiating treatment, adjusting dosage, or conducting a routine review. Advise them to seek urgent medical attention (such as NHS 111 or local crisis teams) if they experience new or worsening suicidal feelings.
- Discuss persistent sexual dysfunction: Inform patients when prescribing or reviewing treatment that some antidepressants carry a risk of sexual dysfunction that may continue after stopping, commonly referred to as PSSD.
- Regular monitoring: Follow relevant NICE guidance (such as NG222) and schedule regular monitoring after starting or altering antidepressant treatment.
- Share safety materials: Provide patients with the safety card (and the ancillary leaflet once introduced in 2027) to aid risk-benefit discussions.
- Report side effects: Submit any suspected adverse drug reactions via the Yellow Card scheme (website, app, or integrated clinical systems).
