DRUG SAFETY UPDATE: Antidepressants: new safety measures for all patients to improve communication of the risk of suicidal thoughts and behaviours and persistent sexual dysfunction

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.

• 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
• When it becomes available in 2027, you will also receive a supporting safety (ancillary) leaflet explaining the benefits and risks of treatment options to help you have informed discussions with your healthcare professional about taking your medicine safely
• Report suspected side effects via the Yellow Card scheme