An Expert Working Group\u00a0(EWG)\u00a0of the Commission on Human Medicines (CHM), advising\u00a0the Medicines and Healthcare Products Regulatory Agency (MHRA), has concluded\u00a0a\u00a0detailed\u00a0review into how the\u00a0potential\u00a0risks associated with 28 antidepressant medicines are communicated\u00a0to patients\u00a0within the Patient Information Leaflet (PIL).\u00a0<\/p>\n
The review\u00a0was\u00a0launched\u00a0after\u00a0concerns were raised\u00a0by families and patients that current safety warnings\u00a0in the\u00a0PILs\u00a0for these medicines\u00a0did not clearly explain certain side effects \u2013\u00a0specifically\u00a0suicidal\u00a0behaviours,\u00a0and sexual dysfunction that may continue after the treatment is stopped.\u00a0<\/p>\n
Over the past 18 months, the EWG has heard directly from families, patients, and mental health support organisations. The group considered the real-world experiences of those affected,\u00a0together with the scientific literature, to understand how warnings could be made clearer and more\u00a0easily understood by\u00a0patients.\u00a0<\/p>\n
Based on the group\u2019s\u00a0recommendations, the\u00a0CHM has advised that the wording in the PILs\u00a0provided with antidepressant medications\u00a0should be strengthened to provide greater clarity on the risk of suicidal behaviour. The revised text will be further developed through user testing\u00a0to ensure\u00a0it is\u00a0as clear and\u00a0effective\u00a0as possible, and\u00a0the MHRA is exploring a range of engagement options to take this advice forward.\u00a0\u00a0<\/p>\n
The CHM has also recommended updates to the PILs for certain antidepressants to better reflect patient feedback and emerging evidence on the potential for sexual dysfunction that may\u00a0continue\u00a0after stopping treatment.\u00a0<\/p>\n
Several\u00a0additional\u00a0communication measures have been agreed, including:\u00a0<\/p>\n
the introduction of a patient card\u00a0to be given to patients\u00a0by their healthcare professional or included in the medicine pack\u00a0and available digitally\u00a0to further highlight the risk\u00a0of\u00a0suicidal behaviour;\u00a0<\/p>\n
an ancillary leaflet to support discussions between patients and healthcare professionals\u00a0regarding\u00a0the risk of suicidal behaviour\u00a0developed with wider healthcare system partners\u00a0<\/p>\n
The MHRA is\u00a0engaging\u00a0with\u00a0the\u00a0National Institute for Health and Care Excellence (NICE), the British National Formulary (BNF), and the Royal Colleges of General Practice and Psychiatrists\u00a0to improve consistency of safety messaging\u00a0in a range of\u00a0additional\u00a0communications.\u00a0<\/p>\n
The MHRA recognises that many families and patients are waiting to\u00a0see the final products that have been developed\u00a0as a result of\u00a0the\u00a0review.\u00a0While regulatory processes\u00a0are\u00a0ongoing there are limitations in the level of detail the MHRA is able to communicate. As soon as\u00a0the regulatory position is finalised,\u00a0the MHRA is committed to communicating\u00a0on the final products\u00a0as quickly as possible.\u00a0<\/p>\n
Patients should continue taking their medicines as prescribed and not stop or change treatment without first speaking to a doctor or mental health professional.\u00a0Please also read the PIL which\u00a0contains\u00a0important information\u00a0about your medicine.\u00a0Anyone experiencing side effects should seek medical advice and report suspected side effects via the\u00a0Yellow Card scheme<\/a>.\u00a0<\/p>\n Notes to Editors:\u202f\u00a0<\/p>\n Antidepressants, including selective serotonin reuptake inhibitors (SSRIs), are widely used for the treatment of depression and other mental health conditions. The MHRA rigorously\u00a0monitors\u00a0the safety of these medicines, including side effects and emerging evidence.\u00a0<\/p>\n As well as having beneficial effects, antidepressants can cause side effects in some people, and in some cases these can be severe. Details of\u00a0possible side\u00a0effects are provided in the Patient Information Leaflets (PILs) accompanying these medicines.\u00a0<\/p>\n All known side effects associated with individual antidepressants are outlined in the Summary of Product Characteristics (SmPC) for healthcare professionals and reflected in\u00a0lay\u00a0language\u00a0in\u00a0the PILs which can be found in the medicine packs.\u00a0<\/p>\n If\u00a0you\u2019re\u00a0having suicidal thoughts, help is available now. You can call NHS 111 (24 hours every day), Samaritans on 116 123, or text \u201cSHOUT\u201d to 85258. Find more information and support options on the\u00a0NHS website<\/a>.\u00a0<\/p>\n The\u00a0Commission on Human Medicines (CHM)<\/a>\u00a0is an independent statutory body, whose members are appointed directly by ministers. Members are not employees of the Agency and are appointed to advise government (Health Ministers), through the licensing authority (the Medicines and Healthcare products Regulatory Agency (MHRA)).\u00a0<\/p>\n