Summary of the latest safety advice for medicines and medical device users
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
New safety measures are now being implemented for all patients taking antidepressant medications. This follows completion of a detailed review, involving patients and their families, into how the risks of suicidal thoughts and behaviours, and persistent sexual dysfunction are communicated in the patient information leaflets (PILs) that accompany antidepressant medications. These changes involve a new boxed warning in the PIL, a new patient card, and a supporting safety (ancillary) leaflet. The term post SSRI sexual dysfunction (“PSSD”) is also being added to the PIL for some antidepressant medications.
Key Advice for Healthcare Professionals:
- discuss with patients when starting or changing the dose of an antidepressant or at their next review, the risk of suicidal thoughts and behaviours. Advise patients to seek urgent medical attention if they experience new or worsening feelings of suicidal intent in relation to starting an antidepressant, especially early in treatment or following dose changes
- discuss with patients when starting or changing the dose of an antidepressant, or at their next review, that there is evidence that some antidepressants are associated with a risk of sexual dysfunction and that symptoms may continue after stopping treatment with certain antidepressants. Some patients refer to this as “PSSD”
- follow the relevant NICE guidance and monitor your patients regularly after starting treatment with an antidepressant
- give your patient the safety (ancillary) leaflet when it becomes available in 2027 to support your risks and benefits discussions
- report suspected adverse reactions associated with antidepressants on a Yellow Card
Key Advice for Healthcare Professionals to Provide to Patients:
- if you have new or worsening suicidal thoughts, particularly when starting or changing dose of antidepressants, seek urgent medical attention. You can call NHS 111, or your local mental health crisis team, Samaritans on 116 123, or text “SHOUT” to 85258. You can find more information and support options on the NHS website
- there is the potential for you to experience sexual dysfunction with some antidepressants, which may continue even after you stop the medicine. Please contact your healthcare professional if you have any concerns
- these are not new risks for these medicines, but it is important to be aware of them
- do not stop taking your medicine without first speaking to your healthcare professional
- please also read the patient card and the Patient Information Leaflet which contains important information about your medicine
Excerpt from the official page. The original is authoritative. Continue reading at UK MHRA ↗