MHRA introduces new safeguards to strengthen antidepressant safety…

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.”

As a result of this review, patient information leaflets for antidepressants will be updated, including a new boxed warning signposting to information on suicidal thoughts and behaviours, making information easier to find. The expectation is that a new patient card will be included in or on the medicine box to reinforce key safety messaging and help patients and carers understand how and when to get further support.

Patient information leaflets for certain antidepressants will be updated to include the term ‘Post SSRI Sexual Dysfunction’ (PSSD), to explain the risk of symptoms continuing after stopping treatment. This update aims to better reflect patient experiences and existing safety information.

Finally, a supporting safety (ancillary) leaflet is being developed by the MHRA with the wider healthcare system, which will be given to patients at their first appointment discussing antidepressants. It will describe the key risks and benefits to support informed decision making about their treatment. This safety leaflet will also be given to patients who are already receiving antidepressants. This will be available in 2027.

Chris Bird, programme manager for patient safety at NICE, said:

“This review will ensure patients and healthcare professionals have the most up to date information to help them make crucial decisions on treatment and support.

“We are grateful to have collaborated with the MHRA on the review, with NICE colleagues joining its expert working group.

“As with all new safety advice issued from the MHRA, we will consider the implications of this advice on published NICE guidance and review our recommendations if required.”

We will continue to work with partners across the healthcare system to support more consistent communication of risks associated with antidepressant medicines. This includes updates to prescribing resources, clinical guidance and patient information materials to better meet the needs of those who use these medicines.

A detailed Public Assessment Report has been published alongside the updated safety information for patients and healthcare professionals.

Notes

• The full Drug Safety Update can be accessed here.
• The MHRA continuously monitors the safety of these medicines, including side effects and emerging evidence. Anyone who suspects they are having a side effect are encouraged to talk to their trusted healthcare professional and report it directly to the Yellow Card scheme.
• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
• The MHRA is an executive agency of the Department of Health and Social Care.

SOURCE: GOV