The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced changes to antidepressant safety information on Thursday, 15 October 2026, following a review involving patients, families, and independent experts.
According to the MHRA’s official announcement, the measures are designed to make existing warnings about suicidal thoughts and behaviours, and sexual problems that may continue after treatment, clearer to patients and healthcare professionals.
What Is Changing?
Patient information leaflets will carry a more prominent boxed warning about suicidal thoughts and behaviours, including advice on where to get help. A new patient card will reinforce the safety messages and is expected to be available in electronic and physical formats.
For certain antidepressants, leaflets will also include the term “Post-SSRI Sexual Dysfunction” (PSSD) to describe sexual symptoms that may continue after treatment has stopped. The regulator says these risks are already recognised; the changes are intended to improve how they are explained.
The MHRA Drug Safety Update lists medicines covered by the persistent sexual dysfunction warning, including sertraline, fluoxetine, citalopram, escitalopram and venlafaxine. The list is not limited to these examples.
When Will Patients See the Changes?
The measures are being introduced in stages. Electronic information and patient cards are expected to become available before all physical medicine packs have been updated. Patients should not assume that every box already contains the new material.
A separate supporting leaflet explaining the benefits, risks, and treatment alternatives is being developed with healthcare partners and is expected in 2027.
Why the Review Took Place
The review followed concerns from patients and families that warnings were not clear enough. The MHRA’s published assessment examines how information about suicidal thoughts and persistent sexual dysfunction is communicated. An expert group met between May 2024 and July 2025, and the Commission on Human Medicines considered its recommendations in September 2025.
Advice for Patients
The MHRA advises patients not to stop taking prescribed antidepressants without first speaking to a healthcare professional. Anyone experiencing new or worsening suicidal thoughts should seek urgent help. NHS 111 and local mental health crisis services can provide support; call 999 if someone is in immediate danger.
Patients who experience concerning side effects should speak to a healthcare professional. Suspected adverse reactions can also be reported through the UK Yellow Card scheme.
