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Packs of antidepressant medication will feature risk warnings around suicidal ideation and persistent sexual dysfunction as patient information leaflets (PILs) are updated, the MHRA has said.

The move follows a review by the Commission on Human Medicines (CHM), which recommended that regulatory action be undertaken to reinforce “consistent safety messaging,” with the MHRA subsequently working with the Patients Association “to refine and finalise” the warnings.

PILs will be updated to include a boxed warning highlighting information on suicidal thoughts and behaviours and signposting patients to support.

The term ‘post SSRI sexual dysfunction (PSSD)’ will also be included in PILs for some medications to highlight that some patients experience sexual dysfunction after discontinuing antidepressants.

A new patient card will be made available in digital or “credit card-sized” hard copies to reinforce key safety messages, and a new ancillary safety leaflet will carry information on  “the benefits, risks and alternatives for antidepressants,” said the MHRA.

The MHRA said: “The leaflet is intended to be given out by the healthcare professional at the first consultation for new patients or the next consultation for existing patients.

“As its implementation requires collaboration across the healthcare system, the safety (ancillary) leaflet will become available in 2027.”

Further work will be carried out in the coming months to help the wider healthcare system update their public-facing information on the risk of suicidal thoughts and behaviours among patients taking antidepressants, for example through updating the BNF and NICE guidelines.

The MHRA advised healthcare professionals to discuss the risks of suicidal thoughts and behaviours with patients when they are starting or changing their dose of antidepressants, or at their next review.
MHRA chief safety officer Dr Alison Cave said: “Patients need clear and accessible information about the benefits and risks of medicines so they can make informed decisions.  

“We are incredibly grateful for the valuable contributions of patients, families, clinicians and experts to this review.  

“These measures will help ensure patients, carers and healthcare professionals can have more informed conversations about the benefits and risks associated with antidepressant medicines, and better support people throughout their treatment.” 

“Antidepressants are effective medicines for the treatment of depression and other conditions. When used appropriately and under clinical supervision, for the vast majority of individuals, the benefits outweigh the risks. The aim is not to discourage use, but to improve the prominence and clarity of the existing warnings.  

“It’s imperative that patients do not stop taking these medicines without first speaking to their healthcare professional.” 

Related: Antidepressant prescriptions on the increase in England, reveals latest NHSBSA figures