UK Regulator Adds Antidepressant Safety Measures: Boxed Leaflet Warnings, New Patient Card and PSSD Labelling
The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced in London in October that, following a review involving patients and families, new safety measures are being introduced for all antidepressant patients in the UK. Patient information leaflets will carry a new boxed warning, supported by a new patient card and an ancillary safety leaflet, available in 2027, and the term post-SSRI sexual dysfunction (PSSD) will be added to the leaflets of some antidepressants.
The MHRA said healthcare professionals should discuss with patients the risks of suicidal thoughts and behaviours and of sexual dysfunction that may persist after stopping treatment, particularly when starting treatment or changing dose. Patients who need urgent help are advised to contact NHS 111, call the Samaritans on 116 123, or text 'SHOUT' to 85258.
The agency stressed that the risks are not new; the measures are intended to make sure patients are fully informed before they start an antidepressant. Patients are reminded not to stop their medication without professional advice, as stopping suddenly can itself cause problems. Any suspected side effects can be reported through the Yellow Card scheme.
The measures are set out in a Drug Safety Update published in the MHRA's October Safety Roundup and apply to all antidepressant products in the UK.
Source: GSM · USA (original Chinese edition)
Photo: 手持泡罩包装的药片（资料图）。Shixart1985 摄，CC BY 2.0，经 Wikimedia Commons。 / A person holds a blister pack of pills (file photo). Photo by Shixart1985, CC BY 2.0, via Wikimedia Commons.
