Antidepressant PIL should provide ‘greater clarity’ on the risk of suicidal behaviour

The wording of Patient Information Leaflets (PILs) for antidepressants should be altered to better communicate the potential risks of taking them, an Expert Working Group (EWG) of the Commission on Human Medicines (CHM) has said.

This follows a review into how the potential risks associated with 28 antidepressant medicines are communicated with patients within the PIL, which heard from families, patients, and mental health support organisations.

The review was launched after concerns were raised by families and patients that the current safety warnings in the PILs did not clearly explain certain side effects – specifically suicidal behaviours, and sexual dysfunction that may continue after the treatment is stopped.

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Based on the review’s findings, the CHM has advised that the wording in the PILs should be ‘strengthened’ to better convey the risk of suicidal behaviour, and the medicines regulator is exploring a range of options to take this forward.

Several additional communication measures have been agreed, including:

• The introduction of a patient card to be given to patients by their healthcare professional or included in the medicine pack to further highlight the risk of suicidal behaviour;
• A leaflet to support discussions between patients and healthcare professionals about the risk of suicidal behaviour.

The Medicines and Healthcare products Regulatory Agency (MHRA) said it was engaging with the National Institute for Health and Care Excellence (NICE), the British National Formulary (BNF), and the Royal Colleges of General Practice and Psychiatrists to improve consistency of safety messaging.

Antidepressants, including selective serotonin reuptake inhibitors (SSRIs), are used for the treatment of depression and other mental health conditions.

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In October, researchers put together the first detailed comparison of side effects associated with different antidepressants which highlights large variation in their impact on the body.

The research preceded the addition of medications used to treat depression to the New Medicine Service (NMS) in October.

An expansion which Hammaad Patel, national pharmacy integration lead at NHS England, said was a ‘step change for the staff’ delivering the service.

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‘People newly prescribed with antidepressants are likely to present with different ideas, concerns and expectations about their new medicines and consequently, pharmacists will need to take this into consideration and reflect on how they will deliver the service in a safe, effective and appropriate manner,’ he added.

The Pharmacist also recently reported that sertraline, one of the UK’s most commonly prescribed antidepressants, can improve key symptoms of depression such as low mood and suicidal thoughts within two weeks of treatment.