MHRA orders updated safety warnings and patient cards for antidepressants

What was announced

The Medicines and Healthcare products Regulatory Agency (MHRA) published changes to how risk information is provided for antidepressant medicines. The Commission on Human Medicines began the review after hearing from patients and relatives who raised concerns about existing warnings.

The regulator set out several packaging and communication updates:

• Boxed warnings will appear on patient leaflets to signpost risks of suicidal thoughts and behaviours.
• A patient safety card is expected to be placed inside or on the medicine box to highlight support routes.
• Leaflets for certain antidepressants will include the term "Post SSRI Sexual Dysfunction" (PSSD) to describe symptoms that persist after stopping the medicine.
• A supporting safety leaflet will be produced with the wider health system, due in 2027, for patients at their first appointment or those already taking the drugs.

What it means

People who receive antidepressants will see updated inserts in their prescription boxes. The MHRA stated that the updates aim to make warnings clearer rather than stop people from using the medicines. Dr Alison Cave, MHRA Chief Safety Officer, said that benefits outweigh risks for the vast majority of people when taken under clinical supervision. She also stated that patients must speak to a healthcare worker before stopping their medicine.

Prescribers and official bodies will also adjust their guidance. The National Institute for Health and Care Excellence (NICE) stated that it will review its published guidelines to see if changes are required. Anyone who suspects they have experienced a side effect can report it directly through the UK Yellow Card scheme.

What the announcement does not tell us

The announcement leaves several practical details unaddressed. It does not name the specific antidepressant drugs that will carry the new PSSD term, referring only to "certain antidepressants".

It also gives no exact date for when updated boxes and patient cards will arrive on pharmacy shelves, noting only that an extra safety leaflet will appear in 2027.

The release does not detail what specific changes NICE might make to its clinical recommendations. Finally, it does not explain how clinicians will monitor whether patients actually receive the forthcoming safety card and leaflet during appointments.