The Medicines and Healthcare products Regulatory Agency (MHRA) is implementing new safeguards to enhance the communication of key risks linked to antidepressant medicines. These changes follow an extensive review initiated by the Commission on Human Medicines (CHM), prompted by patient and family concerns.
The review focused on how information regarding suicidal thoughts and behaviours, and sexual dysfunction that persists after treatment, is presented in patient information leaflets. Dr Alison Cave, MHRA Chief Safety Officer, stated that patients require clear and accessible information to make informed decisions.
As a result, patient information leaflets for antidepressants will be updated to include a new boxed warning signposting to information on suicidal thoughts and behaviours. Additionally, leaflets for certain antidepressants will incorporate the term 'Post SSRI Sexual Dysfunction' (PSSD) to explain the risk of symptoms continuing after stopping treatment.
The MHRA is also developing a supporting safety leaflet, in collaboration with the wider healthcare system, which will be provided to patients at their first appointment discussing antidepressants. This leaflet, describing key risks and benefits, will also be given to patients already receiving antidepressants and is expected to be available in 2027.