�������˰�

Summary

New safety measures are now being implemented for all patients taking
antidepressant medications. This follows completion of a detailed review,
involving patients and their families, into how the risks of suicidal
thoughts and behaviours, and persistent sexual dysfunction are communicated
in the patient information leaflets (PILs) that accompany antidepressant
medications. These changes involve a new boxed warning in the PIL,
a new patient card, and a supporting safety (ancillary) leaflet.

The term post SSRI sexual dysfunction (“PSSD”) is also being added to the
PIL for some antidepressant medications.

Advice for Healthcare Professionals

• discuss with patients when starting or changing the dose of an
  antidepressant or at their next review, the risk of suicidal thoughts
  and behaviours. Advise patients to seek urgent medical attention if
  they experience new or worsening feelings of suicidal intent in relation
  to starting an antidepressant, especially early in treatment or following
  dose changes
• discuss with patients when starting or changing the dose of an
  antidepressant, or at their next review, that there is evidence that
  some antidepressants^[1]
  are associated with a risk of sexual dysfunction and that symptoms may
  continue after stopping treatment with certain antidepressants.
  Some patients refer to this as “PSSD”
• follow the relevant NICE guidance^[2]
  and monitor your patients regularly after starting treatment with an
  antidepressant
• give your patient the safety (ancillary) leaflet when it becomes
  available in 2027 to support your risks and benefits discussions
• report suspected adverse reactions associated with antidepressants on a
  

Advice for Healthcare Professionals to Provide to Patients

• if you have new or worsening suicidal thoughts, particularly when
  starting or changing dose of antidepressants, seek urgent medical
  attention.
  
• there is the potential for you to experience sexual dysfunction with
  some antidepressants, which may continue even after you stop the
  medicine. Please contact your healthcare professional if you have
  any concerns
• these are not new risks for these medicines, but it is important
  to be aware of them
• 
  do not stop taking your medicine without first speaking to your
  healthcare professional
  
• please also read the patient card and the Patient Information Leaflet
  which contains important information �������˰� your medicine
• when it becomes available in 2027, you will also receive a supporting
  safety (ancillary) leaflet explaining the benefits and risks of
  treatment options to help you have informed discussions with your
  healthcare professional �������˰� taking your medicine safely
• report suspected side effects via the
  

Background

A Commission on Human Medicines (CHM) Expert Working Group (EWG) on the
effectiveness of antidepressant risk minimisation measures was convened
in response to concerns raised by patients and their families �������˰�
whether patient information leaflets (PILs) adequately communicate the
risks of suicidal thoughts and behaviours, and sexual dysfunction where
symptoms may continue after stopping treatment.

The EWG met between May 2024 and July 2025 and their recommendations
were considered by the CHM in September 2025.

Central to the considerations of the EWG were the views of patients and
families �������˰� the effectiveness of warnings in the current antidepressants’
PILs. The EWG considered the views in the context of the literature
published since 2019, when the regulatory position on suicidal thoughts
and behaviours, and sexual dysfunction where symptoms continued were
last reviewed at a committee level.

The EWG heard directly from the families of some patients and from
individual patients who shared their experiences and suggestions for
improvements to safety messaging.

The EWG considered the patients’ and families’ views on the need for
additional measures to raise awareness of warnings �������˰� the risk of
suicidal thoughts and behaviours, and sexual dysfunction where symptoms
may continue after stopping treatment. They made recommendations to
the CHM on regulatory options.

The CHM advised that updates to strengthen the wording on the risk of
suicidal thoughts and behaviours in the PILs should be developed through
user testing with patients representing a range of mental health
conditions. The MHRA subsequently worked with the Patients Association,
who brought together a focus group of patients to provide further feedback,
to refine and finalise the updated wording and format of the PILs.

New measures

The Commission on Human Medicines (CHM) has advised the MHRA on several
regulatory actions and the need for consistent safety messaging across
the healthcare system. These include:

• A new boxed warning in the PILs to better highlight information on
  suicidal thoughts and behaviours, and signpost to where patients
  can get help.
• A new patient card available in digital or hard copy formats to reinforce
  key safety messages. The expectation is that the hard copy card will
  be designed to be credit card sized and easy for patients to carry.
  Initially the card will be available electronically and may be given
  to the patient by dispensers as an interim measure ahead of cards
  becoming available. A link to the electronic card will be provided
  in the DHPC and is also available via the following QR code:

• The term “Post SSRI Sexual Dysfunction” (“PSSD”) will be added to the
  PILs of antidepressants associated with a risk of sexual dysfunction
  that may continue even after the drug is stopped^[1].
  Some patients refer to this as post selective serotonin reuptake
  inhibitors (SSRI) sexual dysfunction (“PSSD”). This will better reflect
  the experiences of patients and help raise awareness.
• A new safety (ancillary) leaflet is being developed jointly with other
  healthcare system partners, to describe specific risks and benefits
  in more detail. This will provide patients with specific information
  on the benefits, risks and alternatives for antidepressants.
  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.

The CHM advised several actions for the wider healthcare system on the
risk of suicidal thoughts and behaviours in patients taking antidepressants.
The MHRA is coordinating these actions over the coming months, which
include considerations relating to updates of relevant National Institute
for Health and Care Excellence (NICE) guidelines, updates to the British
National Formulary (BNF) and work with the Royal Colleges of General
Practice, Psychiatrists and Pharmacy, and NHS guidance.

A detailed Public Assessment Report (PAR) is now available describing
the sources of data considered by the EWG in reaching their recommendations.
Additionally, updates to the regulatory position and patient safety
information are hosted on the MHRA antidepressant page.

Reporting advice

Healthcare professionals, patients, and caregivers are asked to submit
reports using the Yellow Card scheme electronically using:

• the
  
• the Yellow Card app; download from the Apple App Store or Google Play Store
• some clinical IT systems for healthcare professionals
  (EMIS, SystmOne, Vision, MiDatabank, and Ulysses)

When reporting suspected adverse drug reactions, please provide as much
information as possible, including information �������˰� medical history,
any concomitant medication, onset timing, and treatment dates.

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Additional information

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You can sign up to receive our monthly roundup of safety communications.

For any enquiries, please contact
info@mhra.gov.uk

Stakeholder engagement

• NHS England Patient Safety Team and Specialist Pharmacy Service
• Devolved Administrations
• Royal College of Psychiatrists
• Royal College of GPs
• Patients Association
• Royal College of Pharmacy
• General Pharmaceutical Council
• Community Pharmacy England
• NICE
• Chair of EWG
• College of Mental Health Pharmacy

Article citation:
MHRA Drug Safety Update volume 20, issue 3: October 2026: 1

References

1. Citalopram, escitalopram, duloxetine, fluvoxamine, fluoxetine,
   paroxetine, sertraline, venlafaxine, amitriptyline, nortriptyline