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A working group of the Commission on Human Medicines (CHM) has recommended that patient information leaflets provide greater clarity on the potential risk of suicidal behaviour associated with antidepressants following a detailed 18-month review.

The group, which advises the Medicines and Healthcare Products Regulatory Agency (MHRA), made several recommendations after reviewing possible side effects of 28 antidepressants, including suicidal behaviours and sexual dysfunction and hearing from families, patients and mental health support organisations.

The MHRA said several “communication measures” have been agreed, including the introduction of a patient card which will be supplied by healthcare professionals or included in the medicine pack and will be available digitally “to further highlight the risk of suicidal behaviour” and an ancillary leaflet to support discussions between patients and healthcare professionals.

The MHRA said the group “considered the real-world experiences of those affected, together with the scientific literature, to understand how warnings could be made clearer and more easily understood by patients”.

The review was launched after families and patients raised concerns that current safety warnings in patient leaflets did not clearly explain possible side effects which may continue after treatment has stopped.

“Based on the group’s recommendations, the CHM has advised that the wording in the patient information leaflets provided with antidepressant medications should be strengthened to provide greater clarity on the risk of suicidal behaviour,” the MHRA said.

“The revised text will be further developed through user testing to ensure it is as clear and effective as possible, and the MHRA is exploring a range of engagement options to take this advice forward.”

The MHRA said it was engaging with the National Institute for Health and Care Excellence, the British National Formulary and the Royal Colleges of General Practice and Psychiatrists “to improve consistency of safety messaging in a range of additional communications”.