MHRA introduces new safeguards to strengthen antidepressant safety information following major review

The Medicines and Healthcare products Regulatory Agency (MHRA) is introducing a series of new measures to strengthen how key risks associated with antidepressant medicines are communicated to patients, carers and healthcare professionals.  

The changes follow an extensive review initiated by the Commission on Human Medicines (CHM), in response to concerns raised by both patients and families about how information on two key areas is communicated in patient information leaflets. These are suicidal thoughts and behaviours, and sexual dysfunction that continues after treatment is stopped. 

Throughout the review we engaged directly with patients and families and considered the latest available evidence and expert clinical advice.  

Dr Alison Cave, MHRA Chief Safety Officer, 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.”